Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Diarrhea

In brief

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.

Key facts

Study ID

NCT01177410

Run by

Bausch Health Americas, Inc.

People needed

148

Starts

2010-07-01

Expected to finish

2011-08-01

Last updated by the study team

2019-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Sherwood, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Bristol, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Macon, Georgia, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Wyoming, Michigan, United States
• Study site — Mexico, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Plano, Texas, United States
• Study site — Ogden, Utah, United States
• Study site — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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