Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome With Diarrhea
• Interventions: Drug: Placebo; Drug: Mesalamine Granules 750 mg; Drug: Mesalamine Granules 1500 mg

• Registration Number: NCT01177410
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

The purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of IBS with diarrhea.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-30
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2012-08-21
• Results First Submitted QC: 2012-08-28
• Results First Posted: 2012-09-27
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Male or non-pregnant, non-lactating female subjects Diagnosed with IBS confirmed by the Rome III criteria

Meet the following IBS symptom scores in all categories during the diary eligibility period:

• An average daily score of greater than or equal to 3 for abdominal pain
• An average daily score of greater than or equal to 3 for bloating
• An average daily score of 5 or greater for stool consistency using the Bristol Stool Scale
• Does not have adequate relief of IBS symptoms (weekly reported) over the past 7 days on the first day of screening and on the day of randomization

Exclusion Criteria

• Present with hard or lumpy stools (Type 1 or Type 2) on the Bristol Stool form Scale during the diary eligibility period
• history of inflammatory bowel disease
• has Type 1 or 2 diabetes
• pregnant or lactating
• history of HIV or hepatitis B or C

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Mesalamine Granules 750 mg	Mesalamine Granules 750 mg	-
Mesalamine Granules 1500 mg	Mesalamine Granules 1500 mg	-

Primary Outcome Measures

Name	Time	Method
The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.	3 months	A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Are Monthly Responders in Both Abdominal Pain and Stool Consistency for at Least 2 Months During the 3-month Treatment Period	3 months	A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.