Diarrhea Predominant Irritable Bowel Syndrome Clinical Trial
Official title:
A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Asimadoline in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)
The purpose of this study is to determine whether asimadoline is safe and effective at treating D-IBS.
The primary objective of the study is to compare the efficacy of the two treatments with
respect to improvement in IBS-related abdominal pain severity and reduction in stool
frequency. During the 12-week treatment period, daily IBS-related abdominal pain severity
score and daily frequency of bowel movements will be averaged over each week to determine
average values for each endpoint. For each subject, weekly response to treatment will be
based on the following parameters:
- Decrease from baseline of at least 30% in the average IBS-related daily abdominal pain
severity score
- Decrease from baseline of at least 25% in the average number of daily bowel movements A
subject must meet both criteria to be considered a weekly responder. The primary
efficacy endpoint is based on an "overall study responder," defined as a subject having
6 or more weeks of weekly response to treatment out of the 12 weeks in the treatment
period. Overall study responder will be stratified by timing of bowel preparation and
endoscopy.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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