Validation of Patient-reported outcomes measures for the assessment of Gastroesophageal Reflux Disease (GERD) symptoms - C27

Study identifier:D9120C00027

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Validation of patient-reported outcomes measures for the assessment of GERD symptoms and their subsequent impact on patients with partial response to Proton Pump Inhibitor (PPI) treatment in a two part multi-center phase IIa study including a four week randomised, double-blind, placebo-controlled, parallel-group treatment period

Medical condition

GERD

Phase

Phase 2

Healthy volunteers

Study drug

AZD3355, Placebo, Gelusil®

Sex

All

Actual Enrollment

478

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 01 May 2008

Primary Completion Date: 01 Jan 2009

Study Completion Date: 01 Jan 2009

Study design

Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other

Verification:

Verified 01 Dec 2014 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

AKRON, OH, United States

Location

Research Site

ANAHEIM, CA, United States

Location

Research Site

ANDERSON, SC, United States

Location

Research Site

ARKANSAS CITY, KS, United States

Location

Research Site

ASHEVILLE, NC, United States

Location

Research Site

ATHENS, AL, United States

Location

Research Site

ATLANTA, GA, United States

Location

Research Site

BALTIMORE, MD, United States

Arms	Assigned Interventions
Experimental: AZD3355	Drug: AZD3355 Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks Other Name: Lesogaberan Drug: Gelusil® Chewable tablets taken as needed Other Name: Gelusil®
Placebo Comparator: Placebo	Drug: Placebo capsule. administered as a single dose twice daily for 4 weeks Drug: Gelusil® Chewable tablets taken as needed Other Name: Gelusil®

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
AZD3355	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
Placebo	Placebo capsules twice daily, Gelusil tablets as rescue medication if needed

Participant Flow: Overall Study

	AZD3355	Placebo
STARTED	235	243
COMPLETED	205	218
NOT COMPLETED	30	25
Adverse Event	14	3
Withdrawal by Subject	8	7
Incorrect Enrollment	6	6
Lost to Follow-up	1	4
Severe Non Compliance	1	5

Baseline Characteristics

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

Reporting Groups

	Description
AZD3355	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
Placebo	Placebo capsules twice daily, Gelusil tablets as rescue medication if needed

Baseline Measures

	AZD3355	Placebo	Total
Number of Participants [units: Participants]	235	243	478
Age Continuous [units: Years] Mean ± Standard Deviation	49.7 ± 10.09	47.8 ± 11.5	48.7 ± 11.2
Gender, Male/Female [units: Participants]
Female	145	135	280
Male	90	108	198

Outcome Measures

1. Primary Outcome Measure: Symptom intensity rated by participants twice daily using an electronic Reflux Symptom Questionnaire diary [ Time Frame: Run-in period of 8-12 days and treatment period of 26-30 days ]

Measure Type	Primary
Measure Name	Symptom intensity rated by participants twice daily using an electronic Reflux Symptom Questionnaire diary
Measure Description	Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)
Time Frame	Run-in period of 8-12 days and treatment period of 26-30 days
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.
None of the analyses addressing the objectives related to validation of the patient reported outcome measures were made per treatment arm and can therefore not be reported in this format.

Reporting Groups

	Description
AZD3355	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
Placebo	Placebo capsules twice daily, Gelusil tablets as rescue medication if needed

Measured Values

	AZD3355	Placebo
Number of Participants Analyzed [units:participants]	0	0
Symptom intensity rated by participants twice daily using an electronic Reflux Symptom Questionnaire diary [units: participants]

No statistical analysis provided for Symptom intensity rated by participants twice daily using an electronic Reflux Symptom Questionnaire diary

Serious Adverse Events

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

Reporting Groups

	Description
AZD3355	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
Placebo	Placebo capsules twice daily, Gelusil tablets as rescue medication if needed

Serious Adverse Events

AZD3355

Placebo

Total, serious adverse events

# participants affected / at risk

1/---

2/---

Injury, poisoning and procedural complications

Operative Hemorrhage¹

# participants affected / at risk

1/---

0/---

Psychiatric disorders

Suicide Attemp¹

# participants affected / at risk

0/---

1/---

Cardiac disorders

Myocardial Infarction¹

# participants affected / at risk

0/---

1/---

Respiratory, thoracic and mediastinal disorders

Pulmonary Oedema¹

# participants affected / at risk

0/---

1/---

Respiratory, thoracic and mediastinal disorders

Respiratory Failure¹

# participants affected / at risk

0/---

1/---

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
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
AZD3355	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
Placebo	Placebo capsules twice daily, Gelusil tablets as rescue medication if needed

Other Adverse Events

AZD3355

Placebo

Total, other (not including serious) adverse events

# participants affected / at risk

18/---

7/---

Gastrointestinal disorders

Diarrhoea ¹

# participants affected / at risk

18/---

7/---

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary,

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: AZ shall have 30 days from the proposed final manuscript for any disclosure to review it and may within such time require that submission for publication/disclosure be delayed in order for AZ to file patent applications. If study site/investigator requests permission to publish data(incl oral presentations) it is to be agreed with AZ prior to publ.

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:	Gerard Lynch
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

D9120C00027 Synopsis
Download
D9120C00027_CSP.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Acurian Call Center

877-934-2345

Investigators

Principal Investigator

Debra Silberg

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

D9120C00027 Synopsis

D9120C00027_CSP.pdf

Trial Results Summaries