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

Bausch Health Americas, Inc.637 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

637

Conditions

Non-Constipation Irritable Bowel Syndrome

Interventions

RifaximinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (88)

Outcomes

Primary Outcomes

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).

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? \[Yes/No\]"

Time frame: 4 weeks

Secondary Outcomes

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)

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? \[Yes/No\]."

Time frame: 4 weeks

Data from ClinicalTrials.gov

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Unnamed facility

Anniston, Alabama, United States

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Tempe, Arizona, United States

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Anaheim, California, United States

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Carmichael, California, United States

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Chula Vista, California, United States

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Concord, California, United States

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Garden Grove, California, United States

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Laguna Hills, California, United States

...and 78 more locations