Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• Symptoms of constipation.

• History of other gastrointestinal diseases.

• Type 1 or 2 diabetes.

• Lactose intolerance not controlled by lactose-free diet.