Local Phase IV, gastroesophageal reflux disease (GERD) Sleep Study US

Study identifier:D9612L00122

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment with Esomeprazole 20 mg qd to Placebo qd in Patients with Heartburn and Sleep Disturbances Associated with Gastroesophageal Reflux Disease (GERD)

Medical condition

Gastroesophageal Reflux Disease

Phase

Phase 4

Healthy volunteers

Study drug

Esomeprazole, Placebo

Sex

All

Actual Enrollment

276

Study type

Interventional

Age

18 Years - 85 Years

Date

Study Start Date: 01 Apr 2008

Primary Completion Date: 01 Jul 2008

Study Completion Date: 01 Jul 2008

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2015 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Albuquerque, NM, United States

Location

Research Site

Amarillo, TX, United States

Location

Research Site

Anaheim, CA, United States

Location

Research Site

Bellevue, WA, United States

Location

Research Site

Binghamton, NY, United States

Location

Research Site

Boynton Beach, FL, United States

Location

Research Site

Burbank, CA, United States

Location

Research Site

Burke, VA, United States

Arms	Assigned Interventions
Experimental: Nexium 20mg Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Drug: Esomeprazole Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate Other Name: Nexium
Placebo Comparator: Placebo	Drug: Placebo once daily

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The baseline figures shown will be for the modified intention to treat population. One patient in each treatment group did not receive study drug; therefore, the safety population has one less patient in each treatment than does the randomized study population.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Participant Flow: Overall Study

	Nexium 20 mg	Placebo
STARTED	143^[1]	133^[2]
Met criteria for MITT population	137	125
COMPLETED	138^[3]	124^[4]
NOT COMPLETED	5	9
Adverse Event	1	0
Lost to Follow-up	0	6
Lack of Efficacy	0	2
Withdrawal by Subject	3	0
Incorrect enrollment and other	0	1
New medication after randomization	1	0

[1]	Randomized
[2]	Randomized
[3]	Number of completed patients is based on randomized population (143) minus withdrawals (5).
[4]	Number of completed patients is based on randomized population (133) minus withdrawals (9).

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Baseline Measures

	Nexium 20 mg	Placebo	Total
Number of Participants [units: Participants]	137	125	262
Age Continuous [units: Years] Mean ± Standard Deviation	47.0 ± 11.7	46.8 ± 12.9	46.9 ± 12.3
Gender, Male/Female [units: Participants]
Female	89	85	174
Male	48	40	88

Outcome Measures

1. Primary Outcome Measure: Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study. [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Primary
Measure Name	Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.
Measure Description	Relief of nighttime heartburn on patient’s last 7 days in the study. Relief was defined as a daily diary card response of “none” or 0, on at least 6 of 7 days, allowing for one “mild” or 1 response. Diary card scale (none, mild, moderate, severe).
Time Frame	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study. [units: Percentage of participants]	34.3	10.4

No statistical analysis provided for Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.

2. Secondary Outcome Measure: Change in mean (average) Pittsburgh Sleep Quality index (PSQI) scores from Baseline [ Time Frame: Baseline and 4 weeks ]

Measure Type	Secondary
Measure Name	Change in mean (average) Pittsburgh Sleep Quality index (PSQI) scores from Baseline
Measure Description	To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, “no difficulty” to 3, “severe difficulty.” Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.
Time Frame	Baseline and 4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	134	123
Change in mean (average) Pittsburgh Sleep Quality index (PSQI) scores from Baseline [units: Scores on a scale] Least Squares Mean (Standard Deviation)	-2.93 (0.34)	-1.80 (0.34)

No statistical analysis provided for Change in mean (average) Pittsburgh Sleep Quality index (PSQI) scores from Baseline

3. Secondary Outcome Measure: Achievement of developer-defined good sleep [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Achievement of developer-defined good sleep
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with ‎Gastroesophageal reflux disease (GERD), as measured by achievement of (yes/no) developer-defined good sleep (global Pittsburgh Sleep Quality Index - PSQI score ≤5) at Week 4.
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	21	29
Achievement of developer-defined good sleep [units: Participants]	19	24

No statistical analysis provided for Achievement of developer-defined good sleep

4. Secondary Outcome Measure: Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal reflux disease (GERD) after 1 week of treatment. [ Time Frame: 1 week ]

Measure Type	Secondary
Measure Name	Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal reflux disease (GERD) after 1 week of treatment.
Measure Description	The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of “No” on 7 consecutive days.
Time Frame	1 week
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal reflux disease (GERD) after 1 week of treatment. [units: Participants]	44	23

No statistical analysis provided for Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal reflux disease (GERD) after 1 week of treatment.

5. Secondary Outcome Measure: Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 2 weeks of treatment. [ Time Frame: 2 weeks ]

Measure Type	Secondary
Measure Name	Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 2 weeks of treatment.
Measure Description	The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of “No” on 14 consecutive days.
Time Frame	2 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 2 weeks of treatment. [units: Participants]	54	20

No statistical analysis provided for Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 2 weeks of treatment.

6. Secondary Outcome Measure: Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 4 weeks of treatment. [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 4 weeks of treatment.
Measure Description	The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?”. Complete resolution of Gastroesophageal Reflux Disease (GERD)-related sleep disturbances was defined as a daily diary response of “No” on 7 consecutive days during 4 weeks of treatment.
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 4 weeks of treatment. [units: Participants]	29	14

No statistical analysis provided for Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 4 weeks of treatment.

7. Secondary Outcome Measure: Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) on the patient's last 7 days in the study. [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Secondary
Measure Name	Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) on the patient's last 7 days in the study.
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Complete resolution of sleep disturbances on the patient's last 7 days in the study.
Time Frame	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) on the patient's last 7 days in the study. [units: Participants]	66	27

No statistical analysis provided for Number of patients with complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) on the patient's last 7 days in the study.

8. Secondary Outcome Measure: Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 1 week of treatment [ Time Frame: 1 week ]

Measure Type	Secondary
Measure Name	Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 1 week of treatment
Measure Description	The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.
Time Frame	1 week
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 1 week of treatment [units: Participants]	79	53

No statistical analysis provided for Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 1 week of treatment

9. Secondary Outcome Measure: Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 2 weeks of treatment [ Time Frame: 2 weeks ]

Measure Type	Secondary
Measure Name	Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 2 weeks of treatment
Measure Description	The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.
Time Frame	2 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 2 weeks of treatment [units: Participants]	90	54

No statistical analysis provided for Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 2 weeks of treatment

10. Secondary Outcome Measure: Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 4 weeks of treatment [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 4 weeks of treatment
Measure Description	The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 4 weeks of treatment [units: Participants]	74	45

No statistical analysis provided for Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 4 weeks of treatment

11. Secondary Outcome Measure: Percentage of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) on the patient's last 7 days in the study. [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) on the patient's last 7 days in the study.
Measure Description	The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.
Time Frame	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) on the patient's last 7 days in the study. [units: Percentage of Participants]	71.5	55.2

No statistical analysis provided for Percentage of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) on the patient's last 7 days in the study.

12. Secondary Outcome Measure: Percentage of days without Gastroesophageal Reflux Disease (GERD)-related sleep disturbances during the 4 week period [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Percentage of days without Gastroesophageal Reflux Disease (GERD)-related sleep disturbances during the 4 week period
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD)as measured by: Percent of days without sleep disturbances after 4 weeks of treatment. Each morning of the study, patients registered their answer “Yes” or “No” to the question, “Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?” in the diary card.'
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	124
Percentage of days without Gastroesophageal Reflux Disease (GERD)-related sleep disturbances during the 4 week period [units: Percentage of days] Mean (Standard Deviation)	73.0 (29.7)	59.3 (29.9)

No statistical analysis provided for Percentage of days without Gastroesophageal Reflux Disease (GERD)-related sleep disturbances during the 4 week period

13. Secondary Outcome Measure: Number of days to first relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Number of days to first relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period
Measure Description	The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days, and ‘days to first relief’ was defined as the first day of the 7 days that reached relief of sleep disturbance.
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Number of days to first relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period [units: Days] Median (Full Range)	1 (1 to 21)	3 (1 to 21)

No statistical analysis provided for Number of days to first relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period

14. Secondary Outcome Measure: Number of days to resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Number of days to resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period
Measure Description	The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Number of days to resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period [units: Days] Median (Full Range)	1 (1 to 14)	2 (1 to 21)

No statistical analysis provided for Number of days to resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period

15. Secondary Outcome Measure: Number of days to first complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Number of days to first complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Days to complete resolution of sleep disturbance. Days to complete resolution of sleep disturbances associated with GERD was defined as the number of days until the first day of the first 7‑consecutive-day period during which the patient’s daily diary response was “No” (did not have trouble sleeping due to GERD symptoms).'
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Number of days to first complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period [units: Days] Median (Full Range)	9 (1 to 21)	21 (1 to 21)

No statistical analysis provided for Number of days to first complete resolution of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period

16. Secondary Outcome Measure: Percentage of patients with complete resolution of daytime heartburn after 1 week of treatment [ Time Frame: 1 week ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of daytime heartburn after 1 week of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 1 week of treatment. Results based on MITT population with available data for this outcome measure. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	1 week
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of daytime heartburn after 1 week of treatment [units: Percentage of participants]	22	4

No statistical analysis provided for Percentage of patients with complete resolution of daytime heartburn after 1 week of treatment

17. Secondary Outcome Measure: Percentage of patients with complete resolution of daytime heartburn after 2 weeks of treatment [ Time Frame: 2 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of daytime heartburn after 2 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	2 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of daytime heartburn after 2 weeks of treatment [units: Percentage of participants]	37	11

No statistical analysis provided for Percentage of patients with complete resolution of daytime heartburn after 2 weeks of treatment

18. Secondary Outcome Measure: Percentage of patients with complete resolution of daytime heartburn after 4 weeks of treatment [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of daytime heartburn after 4 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of daytime heartburn after 4 weeks of treatment [units: Percentage of participants]	35	7

No statistical analysis provided for Percentage of patients with complete resolution of daytime heartburn after 4 weeks of treatment

19. Secondary Outcome Measure: Percentage of patients with complete resolution of daytime heartburn on the patient's last 7 days in the study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of daytime heartburn on the patient's last 7 days in the study
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of daytime heartburn on the patient's last 7 days in the study [units: Percentage of participants]	45	9

No statistical analysis provided for Percentage of patients with complete resolution of daytime heartburn on the patient's last 7 days in the study

20. Secondary Outcome Measure: Percentage of patients with complete resolution of nighttime heartburn after 1 week of treatment. [ Time Frame: 1 week ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of nighttime heartburn after 1 week of treatment.
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	1 week
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of nighttime heartburn after 1 week of treatment. [units: Percentage of participants]	23	4

No statistical analysis provided for Percentage of patients with complete resolution of nighttime heartburn after 1 week of treatment.

21. Secondary Outcome Measure: Percentage of patients with complete resolution of nighttime heartburn after 2 weeks of treatment [ Time Frame: 2 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of nighttime heartburn after 2 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	2 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of nighttime heartburn after 2 weeks of treatment [units: Percentage of participants]	36	6

No statistical analysis provided for Percentage of patients with complete resolution of nighttime heartburn after 2 weeks of treatment

22. Secondary Outcome Measure: Percentage of patients with complete resolution of nighttime heartburn after 4 weeks of treatment [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of nighttime heartburn after 4 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of nighttime heartburn after 4 weeks of treatment [units: Percentage of participants]	25	6

No statistical analysis provided for Percentage of patients with complete resolution of nighttime heartburn after 4 weeks of treatment

23. Secondary Outcome Measure: Percentage of patients with complete resolution of nighttime heartburn on the patient's last 7 days in the study. [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of nighttime heartburn on the patient's last 7 days in the study.
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of nighttime heartburn on the patient's last 7 days in the study. [units: Percentage of participants]	42	8

No statistical analysis provided for Percentage of patients with complete resolution of nighttime heartburn on the patient's last 7 days in the study.

24. Secondary Outcome Measure: Percentage of patients with complete resolution of 24-hour heartburn after 1 week of treatment [ Time Frame: 1 week ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of 24-hour heartburn after 1 week of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	1 week
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of 24-hour heartburn after 1 week of treatment [units: Percentage of participants]	16	3

No statistical analysis provided for Percentage of patients with complete resolution of 24-hour heartburn after 1 week of treatment

25. Secondary Outcome Measure: Percentage of patients with complete resolution of 24-hour heartburn after 2 weeks of treatment [ Time Frame: 2 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of 24-hour heartburn after 2 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	2 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of 24-hour heartburn after 2 weeks of treatment [units: Percentage of participants]	30	4

No statistical analysis provided for Percentage of patients with complete resolution of 24-hour heartburn after 2 weeks of treatment

26. Secondary Outcome Measure: Percentage of patients with complete resolution of 24-hour heartburn after 4 weeks of treatment [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of 24-hour heartburn after 4 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of 24-hour heartburn after 4 weeks of treatment [units: Percentage of participants]	30	4

No statistical analysis provided for Percentage of patients with complete resolution of 24-hour heartburn after 4 weeks of treatment

27. Secondary Outcome Measure: Percentage of patients with complete resolution of 24-hour heartburn on the patient's last 7 days in the study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Secondary
Measure Name	Percentage of patients with complete resolution of 24-hour heartburn on the patient's last 7 days in the study
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.
Time Frame	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with complete resolution of 24-hour heartburn on the patient's last 7 days in the study [units: Percentage of participants]	37	5

No statistical analysis provided for Percentage of patients with complete resolution of 24-hour heartburn on the patient's last 7 days in the study

28. Secondary Outcome Measure: Percentage of patients with relief of daytime heartburn after 1 week of treatment [ Time Frame: 1 week ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of daytime heartburn after 1 week of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Results based on MITT population with available data for this outcome measure. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.'
Time Frame	1 week
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of daytime heartburn after 1 week of treatment [units: Percentage of participants]	34	13

No statistical analysis provided for Percentage of patients with relief of daytime heartburn after 1 week of treatment

29. Secondary Outcome Measure: Percentage of patients with relief of daytime heartburn after 2 weeks of treatment [ Time Frame: 2 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of daytime heartburn after 2 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'
Time Frame	2 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of daytime heartburn after 2 weeks of treatment [units: Percentage of participants]	48	14

No statistical analysis provided for Percentage of patients with relief of daytime heartburn after 2 weeks of treatment

30. Secondary Outcome Measure: Percentage of patients with relief of daytime heartburn after 4 weeks of treatment [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of daytime heartburn after 4 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of daytime heartburn after 4 weeks of treatment [units: Percentage of participants]	40	9

No statistical analysis provided for Percentage of patients with relief of daytime heartburn after 4 weeks of treatment

31. Secondary Outcome Measure: Percentage of patients with relief of daytime heartburn on the patient's last 7 days in the study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of daytime heartburn on the patient's last 7 days in the study
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'
Time Frame	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of daytime heartburn on the patient's last 7 days in the study [units: Percentage of participants]	55	14

No statistical analysis provided for Percentage of patients with relief of daytime heartburn on the patient's last 7 days in the study

32. Secondary Outcome Measure: Percentage of patients with relief of nighttime heartburn after 1 week of treatment. [ Time Frame: 1 week ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of nighttime heartburn after 1 week of treatment.
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.
Time Frame	1 week
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of nighttime heartburn after 1 week of treatment. [units: Percentage of participants]	28	9

No statistical analysis provided for Percentage of patients with relief of nighttime heartburn after 1 week of treatment.

33. Secondary Outcome Measure: Percentage of patients with relief of nighttime heartburn after 2 weeks of treatment [ Time Frame: 2 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of nighttime heartburn after 2 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.
Time Frame	2 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of nighttime heartburn after 2 weeks of treatment [units: Percentage of participants]	40	7

No statistical analysis provided for Percentage of patients with relief of nighttime heartburn after 2 weeks of treatment

34. Secondary Outcome Measure: Percentage of patients with relief of nighttime heartburn after 4 weeks of treatment [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of nighttime heartburn after 4 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of nighttime heartburn after 4 weeks of treatment [units: Percentage of participants]	26	6

No statistical analysis provided for Percentage of patients with relief of nighttime heartburn after 4 weeks of treatment

35. Secondary Outcome Measure: Percentage of patients with relief of nighttime heartburn on the patient's last 7 days in the study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of nighttime heartburn on the patient's last 7 days in the study
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.
Time Frame	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of nighttime heartburn on the patient's last 7 days in the study [units: Percentage of participants]	47	13

No statistical analysis provided for Percentage of patients with relief of nighttime heartburn on the patient's last 7 days in the study

36. Secondary Outcome Measure: Percentage of patients with relief of 24-hour heartburn after 1 week of treatment [ Time Frame: 1 week ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of 24-hour heartburn after 1 week of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.
Time Frame	1 week
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of 24-hour heartburn after 1 week of treatment [units: Percentage of participants]	27	5

No statistical analysis provided for Percentage of patients with relief of 24-hour heartburn after 1 week of treatment

37. Secondary Outcome Measure: Percentage of patients with relief of 24-hour heartburn after 2 weeks of treatment [ Time Frame: 2 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of 24-hour heartburn after 2 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.
Time Frame	2 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of 24-hour heartburn after 2 weeks of treatment [units: Percentage of participants]	36	5

No statistical analysis provided for Percentage of patients with relief of 24-hour heartburn after 2 weeks of treatment

38. Secondary Outcome Measure: Percentage of patients with relief of 24-hour heartburn after 4 weeks of treatment [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of 24-hour heartburn after 4 weeks of treatment
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of 24-hour heartburn after 4 weeks of treatment [units: Percentage of participants]	33	5

No statistical analysis provided for Percentage of patients with relief of 24-hour heartburn after 4 weeks of treatment

39. Secondary Outcome Measure: Percentage of patients with relief of 24-hour heartburn on the patient's last 7 days in the study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Secondary
Measure Name	Percentage of patients with relief of 24-hour heartburn on the patient's last 7 days in the study
Measure Description	To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.
Time Frame	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of patients with relief of 24-hour heartburn on the patient's last 7 days in the study [units: Percentage of participants]	45	9

No statistical analysis provided for Percentage of patients with relief of 24-hour heartburn on the patient's last 7 days in the study

40. Secondary Outcome Measure: Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Secondary
Measure Name	Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study
Measure Description	Number and percentage of patients with nighttime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.
Time Frame	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study [units: Percentage of participants]	89.8	83.2

No statistical analysis provided for Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study

41. Secondary Outcome Measure: Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study [ Time Frame: Days 21-28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study
Measure Description	Number of patients with daytime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.
Time Frame	Days 21-28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	137	125
Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study [units: Percentage of participants]	86.1	76

No statistical analysis provided for Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study

42. Secondary Outcome Measure: Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study. [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ]

Measure Type	Secondary
Measure Name	Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.
Measure Description	Number of patients with 24-hour heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.
Time Frame	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	125	137
Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study. [units: Percentage of participants]	89.8	80

No statistical analysis provided for Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.

43. Secondary Outcome Measure: Equivalent Number of hours lost because of sleep disturbances due to Gastroesophageal Reflux Disease (GERD) symptoms (average) [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Equivalent Number of hours lost because of sleep disturbances due to Gastroesophageal Reflux Disease (GERD) symptoms (average)
Measure Description
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	78	74
Equivalent Number of hours lost because of sleep disturbances due to Gastroesophageal Reflux Disease (GERD) symptoms (average) [units: Work hours] Mean (Standard Deviation)	8.9 (11.1)	5.2 (11.7)

No statistical analysis provided for Equivalent Number of hours lost because of sleep disturbances due to Gastroesophageal Reflux Disease (GERD) symptoms (average)

44. Secondary Outcome Measure: Change from Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (average) [ Time Frame: Baseline and 4 weeks ]

Measure Type	Secondary
Measure Name	Change from Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (average)
Measure Description	Degree of sleep disturbance affecting work productivity. 100% is considered to be the worst outcome where there is no ability to work. 0% is considered to be the best outcome, no impairment.
Time Frame	Baseline and 4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	83	78
Change from Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (average) [units: Percentage] Mean (Standard Deviation)	-25.3 (28.7)	-14 (27.4)

No statistical analysis provided for Change from Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (average)

45. Secondary Outcome Measure: Change from Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (average) [ Time Frame: Baseline and 4 weeks ]

Measure Type	Secondary
Measure Name	Change from Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (average)
Measure Description	Equivalent number of work hours missed was derived from questions 2, 4 and 5 of the Work Productivity and Activity Impairment Questionnaire: Sleep Disturbance-GERD (Gastroesophageal Reflux Disease) and summed up with the percent work impairment during the remaining hours that were actually worked.
Time Frame	Baseline and 4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	76	74
Change from Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (average) [units: Percentage] Mean (Standard Deviation)	-24.8 (29.5)	-14.9 (25.9)

No statistical analysis provided for Change from Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (average)

46. Secondary Outcome Measure: Change from Baseline in Percent Activity Impairment Due to Sleep Disturbances (average) [ Time Frame: Baseline and 4 weeks ]

Measure Type	Secondary
Measure Name	Change from Baseline in Percent Activity Impairment Due to Sleep Disturbances (average)
Measure Description	To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, “no difficulty” to 3, “severe difficulty.” Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.
Time Frame	Baseline and 4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	87	78
Change from Baseline in Percent Activity Impairment Due to Sleep Disturbances (average) [units: Percentage] Mean (Standard Deviation)	-25.1 (27.4)	-17.1 (28)

No statistical analysis provided for Change from Baseline in Percent Activity Impairment Due to Sleep Disturbances (average)

47. Secondary Outcome Measure: Monetary value of work hours saved [ Time Frame: Week 4 ]

Measure Type	Secondary
Measure Name	Monetary value of work hours saved
Measure Description	The monetary value of the work hours saved was derived from questions 2,4, and 5 of the WPAI and a standard hourly compensation rate reported by the US Bureau of Labor Statistics (US$28.48 as of June 2008).
Time Frame	Week 4
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results based on MITT population with available data for this outcome measure.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Measured Values

	Nexium 20 mg	Placebo
Number of Participants Analyzed [units:participants]	76	74
Monetary value of work hours saved [units: Monetary value (US dollars)] Least Squares Mean (Standard Deviation)	280.21 (34.88)	156.61 (33.05)

No statistical analysis provided for Monetary value of work hours saved

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Serious Adverse Events

Nexium 20 mg

Placebo

Total, serious adverse events

# participants affected / at risk

0/143 (0.00%)

1/133 (0.75%)

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

0/143 (0.00%)

1/133 (0.75%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.1
2	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Nexium 20 mg	Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo	Capsule once daily (QD)

Other Adverse Events

	Nexium 20 mg	Placebo
Total, other (not including serious) adverse events
# participants affected / at risk	0/143 (0.00%)	0/133 (0.00%)

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If Sponsor does not publish within 2 years after study completion, PI is permitted to publish, with confidential information removed from manuscript. Sponsor will have opportunity to review and approve publication at least 60 days prior to being submitted/disclosed. Sponsor can request, in writing, an additional 90 day embargo.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Clinical Trial Transparency
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=437&filename=CSR-D9612L00122.pdf
Download
CSR-D9612L00122.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Sutdy Information

1-800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Tore Lind

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

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Research Site

Research Site