Overview

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.