Phase 3
Completed N=623
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
Non-Constipation Irritable Bowel Syndrome
Source: ClinicalTrials.gov NCT00731679 ↗
Enrolled (actual)
623
Serious AEs
1.8%
Results posted
Jul 2014
Primary outcomePrimary: 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). — 31.2; 40.8 percentage of responders — p=0.01
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.
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). |
31.2; 40.8 | 0.01 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). |
28.7; 39.5 | 0.005 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00731679). 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. Informational only — not medical advice.