Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) (TARGET 1)

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Non-Constipation Irritable Bowel Syndrome

Treatments: Drug: Placebo; Drug: Rifaximin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00731679

RFIB3007

Details and patient eligibility

About

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.

Enrollment: 623 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed IBS diagnosis per Rome II 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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623 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.

Treatment:

Drug: Placebo

Rifaximin

Experimental group

Description:

Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.

Treatment:

Drug: Rifaximin