Status:
COMPLETED
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Non-Constipation Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.
Eligibility Criteria
Inclusion
- Confirmed IBS diagnosis per Rome II criteria for diagnosis of IBS.
- Colonoscopy within 2 years as part of IBS diagnostic evaluation.
- Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency.
Exclusion
- Symptoms of constipation.
- History of other gastrointestinal diseases.
- Type 1 or 2 diabetes.
- Lactose intolerance not controlled by lactose-free diet.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
637 Patients enrolled
Trial Details
Trial ID
NCT00724126
Start Date
July 1 2008
End Date
September 1 2009
Last Update
November 29 2019
Active Locations (88)
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1
Anniston, Alabama, United States, 36207
2
Birmingham, Alabama, United States, 35205
3
Huntsville, Alabama, United States, 35801
4
Tempe, Arizona, United States, 85282