Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea
NCT ID: NCT01177410
Last Updated: 2019-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
148 participants
INTERVENTIONAL
2010-07-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
placebo capsules once daily for 12 weeks
Mesalamine Granules 750 mg
Mesalamine Granules 750 mg
750 mg mesalamine granules once daily for 12 weeks
Mesalamine Granules 1500 mg
Mesalamine Granules 1500 mg
1500 mg mesalamine granules once daily for 12 weeks
Interventions
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Placebo
placebo capsules once daily for 12 weeks
Mesalamine Granules 750 mg
750 mg mesalamine granules once daily for 12 weeks
Mesalamine Granules 1500 mg
1500 mg mesalamine granules once daily for 12 weeks
Eligibility Criteria
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Inclusion 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
* history of inflammatory bowel disease
* has Type 1 or 2 diabetes
* pregnant or lactating
* history of HIV or hepatitis B or C
18 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Locations
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Sherwood, Arkansas, United States
Anaheim, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Bristol, Connecticut, United States
Boynton Beach, Florida, United States
St. Petersburg, Florida, United States
Macon, Georgia, United States
Shreveport, Louisiana, United States
Ann Arbor, Michigan, United States
Wyoming, Michigan, United States
Mexico, Missouri, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Greensboro, North Carolina, United States
Plano, Texas, United States
Ogden, Utah, United States
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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MGIB2051
Identifier Type: -
Identifier Source: org_study_id
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