Status:
COMPLETED
Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Irritable Bowel Syndrome With Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01177410
Start Date
July 1 2010
End Date
August 1 2011
Last Update
November 21 2019
Active Locations (20)
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1
Sherwood, Arkansas, United States, 72120
2
Anaheim, California, United States, 92801
3
Sacramento, California, United States, 95831
4
San Diego, California, United States, 92108