Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Mesalamine

Criteria

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