Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

Bausch Health Americas, Inc.148 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

148

Conditions

Irritable Bowel Syndrome With Diarrhea

Interventions

PlaceboDRUG

placebo capsules once daily for 12 weeks

Mesalamine Granules 750 mgDRUG

750 mg mesalamine granules once daily for 12 weeks

Mesalamine Granules 1500 mgDRUG

1500 mg mesalamine granules once daily for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Unnamed facility

Sherwood, Arkansas, United States

Unnamed facility

Anaheim, California, United States

Outcomes

Primary Outcomes

The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three 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.

Time frame: 3 months

Secondary Outcomes

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

Time frame: 3 months

Data from ClinicalTrials.gov

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