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

Phase 3

Completed

• Conditions: Non-Constipation Irritable Bowel Syndrome
• Interventions: Drug: Placebo; Drug: Rifaximin

• Registration Number: NCT00724126
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-26
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-29
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Results First Submitted: 2014-06-30
• Results First Submitted QC: 2014-06-30
• Results First Posted: 2014-07-28
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 637

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Rifaximin	Rifaximin	Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.

Primary Outcome Measures

Name	Time	Method
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).	4 weeks	The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.; Adequate relief of global IBS symptoms was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? \[Yes/No\]"

Secondary Outcome Measures

Name	Time	Method
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)	4 weeks	The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.; Adequate relief of bloating was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? \[Yes/No\]."