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Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) (TARGET 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00724126
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : July 28, 2014
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Constipation Irritable Bowel Syndrome Drug: Rifaximin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 637 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin 550 mg TID in the Treatment of Subjects With Non-Constipation Irritable Bowel Syndrome
Study Start Date : July 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
 Drug: Placebo
Experimental: 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.
 Drug: Rifaximin


Outcome Measures
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Primary Outcome Measures :
  1. 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). [ Time Frame: 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 :
  1. 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) [ Time Frame: 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]."



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724126


Locations
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Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Enoch Bortey Bausch Health Americas, Inc.
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00724126    
Other Study ID Numbers: RFIB3008
First Posted: July 29, 2008    Key Record Dates
Results First Posted: July 28, 2014
Last Update Posted: November 29, 2019
Last Verified: November 2019
Keywords provided by Bausch Health Americas, Inc.:
Diarrhea
Rifaximin
IBS
Abdominal pain
Bloating
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents