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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.

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Official Title

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.

A 12-week extension of the Phase III study (D3820C00004) to assess the effect and safety of NKTR-118 in patients with non-cancer-related pain and opioid-induced constipation

NCT ID

Therapeutic Area

Clinical_Study_Report_Synopsis_D3820C00007

D3820C00007 Revised Study Protocol_Redacted (Edition Number 2.0)

Research Site

A Randomized, Double-Blind, Placebo-Controlled 12-Week Extension Study to Assess the Safety and Tolerability of NKTR-118 in Patients with Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

A total of 6 patients (1 patient in the NKTR-118 25 mg group, 2 patients in the NKTR-118 12.5 mg group, 3 patients in the placebo group) had been previously randomized within the NKTR-118 program at a different study center and were excluded from the ITT and Safety analysis sets. Baseline characteristics are summarized using the ITT analysis set.

The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.

The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.

Incidence of patients experiencing at least one adverse event (AE)

Total score

Abdominal symptoms subscore

Rectal symptoms subscore

Stool symptoms subscore

The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.

The modified intent-to-treat(ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The N denotes the number of patients with a baseline and last on-treatment value.

Change from baseline in Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM)

Physical discomfort

Psychosocial discomfort

Worries/concerns

Satisfaction

The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items).  Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.

The modified intent-to-treat (ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.The N denotes the number of patients with a baseline and last on-treatment value.

Change from baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)

The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.

Incidence of patients experiencing AEs that resulted in discontinuation of investigational product (IP)

The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.

Incidence of patients experiencing severe adverse events (SAEs)

Overall Study

Study D380C00007 is an extension study of D3820C00004. Of the patients randomized in D3820C00004, n=302 continued and enrolled into D380C00007. The study duration was up to 14 weeks, consisting of a 12 week treatment period and a follow-up visit 2 weeks after the last dose of study drug. 

Arms	Assigned Interventions
Experimental: NKTR-118 12.5mg	Drug: NKTR-118 12.5 mg oral tablet once daily
Experimental: NKTR-118 25mg	Drug: NKTR-118 25 mg oral tablet once daily
Placebo Comparator: Placebo	Drug: Placebo Oral tablet intake once daily

A 12-week extension of the Phase III study (D3820C00004) to assess the effect and safety of NKTR-118 in patients with non-cancer-related pain and opioid-induced constipation

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Clinical_Study_Report_Synopsis_D3820C00007

D3820C00007 Revised Study Protocol_Redacted (Edition Number 2.0)

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator