- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00724126
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) (TARGET 2)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Anniston, Alabama, United States, 36207
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Birmingham, Alabama, United States, 35205
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Huntsville, Alabama, United States, 35801
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Arizona
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Tempe, Arizona, United States, 85282
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California
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Anaheim, California, United States, 92801
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Carmichael, California, United States, 95608
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Chula Vista, California, United States, 91910
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Concord, California, United States, 94520
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Garden Grove, California, United States, 92840
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Laguna Hills, California, United States, 92653
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Lakewood, California, United States, 90712
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Los Angeles, California, United States, 90048
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Monterey, California, United States, 93940
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Orange, California, United States, 92868
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Roseville, California, United States, 95661
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San Carlos, California, United States, 94070
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San Francisco, California, United States, 94117
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Connecticut
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Bristol, Connecticut, United States, 06010
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Hamden, Connecticut, United States, 06518
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Delaware
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Newark, Delaware, United States, 19713
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Florida
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Boca Raton, Florida, United States, 33486
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Hollywood, Florida, United States, 33021
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Largo, Florida, United States, 33777
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New Port Richey, Florida, United States, 34655
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New Smyrna Beach, Florida, United States, 32168
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Port Orange, Florida, United States, 32127
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Saint Petersburg, Florida, United States, 33709
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Tampa, Florida, United States, 33607
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Zephyrhills, Florida, United States, 33542
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Georgia
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Atlanta, Georgia, United States, 30342
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Macon, Georgia, United States, 31201
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Indiana
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Elkhart, Indiana, United States, 46514
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Kansas
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Kansas City, Kansas, United States, 66160
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Topeka, Kansas, United States, 66606
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Kentucky
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Bowling Green, Kentucky, United States, 42104
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Louisiana
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Metairie, Louisiana, United States, 70006
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Monroe, Louisiana, United States, 71201
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Maryland
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Baltimore, Maryland, United States, 21229
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Elkridge, Maryland, United States, 21075
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Massachusetts
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Wellesley, Massachusetts, United States, 02481
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Michigan
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Ann Arbor, Michigan, United States, 48109
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Troy, Michigan, United States, 48098
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Wyoming, Michigan, United States, 49519
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Missouri
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Mexico, Missouri, United States, 65265
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New Jersey
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Sicklerville, New Jersey, United States, 08081
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Voorhees, New Jersey, United States, 08043
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New Mexico
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Albuquerque, New Mexico, United States, 87102
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New York
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Great Neck, New York, United States, 11021
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Mineola, New York, United States, 11501
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New York, New York, United States, 10016
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North Massapequa, New York, United States, 11758
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Pomona, New York, United States, 10970
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Stony Brook, New York, United States, 11790
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North Carolina
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Boone, North Carolina, United States, 28607
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Chapel Hill, North Carolina, United States, 27514
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Charlotte, North Carolina, United States, 28209
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Greensboro, North Carolina, United States, 27408
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Greensboro, North Carolina, United States, 27403
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New Bern, North Carolina, United States, 28562
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Wilmington, North Carolina, United States, 28401
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Winston-Salem, North Carolina, United States, 27103
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Ohio
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Canton, Ohio, United States, 44718
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Cincinnati, Ohio, United States, 45242
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Dayton, Ohio, United States, 45415
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Pennsylvania
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Downingtown, Pennsylvania, United States, 19335
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Newtown, Pennsylvania, United States, 18940
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Pittsburgh, Pennsylvania, United States, 15206
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Sayre, Pennsylvania, United States, 18840
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South Carolina
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Anderson, South Carolina, United States, 29621
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Columbia, South Carolina, United States, 29203
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Tennessee
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Bristol, Tennessee, United States, 37620
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Chattanooga, Tennessee, United States, 37421
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Franklin, Tennessee, United States, 37067
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Germantown, Tennessee, United States, 38138
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Jackson, Tennessee, United States, 38301
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Kingsport, Tennessee, United States, 37660
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Texas
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El Paso, Texas, United States, 79902
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Houston, Texas, United States, 77024
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Lewisville, Texas, United States, 75057
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Plano, Texas, United States, 75075
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San Antonio, Texas, United States, 78229
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Utah
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Salt Lake City, Utah, United States, 84107
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Vermont
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Burlington, Vermont, United States, 05401
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Virginia
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Chesapeake, Virginia, United States, 23320
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Fairfax, Virginia, United States, 22031
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Washington
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Spokane, Washington, United States, 99208
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
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Milwaukee, Wisconsin, United States, 53215
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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]" |
4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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]." |
4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Enoch Bortey, Bausch Health Americas, Inc.
Publications and helpful links
General Publications
- Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.
- Schoenfeld P, Pimentel M, Chang L, Lembo A, Chey WD, Yu J, Paterson C, Bortey E, Forbes WP. Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double-blind, placebo-controlled trials. Aliment Pharmacol Ther. 2014 May;39(10):1161-8. doi: 10.1111/apt.12735. Epub 2014 Apr 3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RFIB3008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Constipation Irritable Bowel Syndrome
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