Phase 3 N=637 Randomized Quadruple-blind Treatment

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

Non-Constipation Irritable Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00724126 ↗

Enrolled (actual)

637

Serious AEs

2.2%

Results posted

Jul 2014

Primary outcome: Primary: Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6). — 32.2; 40.6 percentage of responders — p=0.03

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rifaximin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch Health Americas, Inc.
Primary completion: Aug 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).	32.2; 40.6	0.03 sig
SECONDARY Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)	31.9; 41.0	0.02 sig

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00724126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.