Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550 mg three times a day in patients with IBS with diarrhea who respond to initial treatment of rifaximin 550 mg three times a day.

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

Details

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

Criteria

Inclusion Criteria:

• IBS confirmed by Rome III diagnostic criteria.

• At least 18 years of age.

• Colonoscopy within the past 10 years to rule out inflammatory bowel disease; or flexible sigmoidoscopy if < 50 years of age or previous colonoscopy > 10 years prior.

• Willing to maintain a stable diet. including vitamins, supplements, and nutraceuticals.

Exclusion Criteria:

• Diabetes (Type 1 or 2).

• Lactose intolerance and not controlled by a lactose-free diet.

• Pregnant or planning to become pregnant or is lactating.

• History of HIV or hepatitis B or C.

• Participation in investigational study within past 30 days.

• Taking rifaximin or any other antibiotic within past 60 days.

• Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition.

• History of GI surgery.