Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
TARGET 1
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
1 other identifier
interventional
623
2 countries
96
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2008
Shorter than P25 for phase_3
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 16, 2008
CompletedFirst Posted
Study publicly available on registry
August 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
July 28, 2014
CompletedNovember 29, 2019
November 1, 2019
1.1 years
July 16, 2008
June 30, 2014
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
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
Secondary Outcomes (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).
4 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORSubjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Rifaximin
EXPERIMENTALSubjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Symptoms of constipation.
- History of other gastrointestinal diseases.
- Type 1 or 2 diabetes.
- Lactose intolerance not controlled by lactose-free diet.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
Unknown Facility
Hueytown, Alabama, 35023, United States
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Phoenix, Arizona, 85050, United States
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Sierra Vista, Arizona, 85635, United States
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Tucson, Arizona, 85741, United States
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Little Rock, Arkansas, 72204, United States
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Little Rock, Arkansas, 72205, United States
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Sherwood, Arkansas, 72120, United States
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Anaheim, California, 92801, United States
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Lancaster, California, 93534, United States
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Los Angeles, California, 90045, United States
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Murrieta, California, 92562, United States
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San Diego, California, 92108, United States
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Lakewood, Colorado, 80215, United States
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Bridgeport, Connecticut, 06606, United States
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Torrington, Connecticut, 06790, United States
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Altamonte Springs, Florida, 32701, United States
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Boynton Beach, Florida, 33426, United States
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Gainesville, Florida, 32607, United States
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Hollywood, Florida, 33021, United States
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Jupiter, Florida, 33458, United States
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Lauderdale Lakes, Florida, 33319, United States
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Maitland, Florida, 32751, United States
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Naples, Florida, 34102, United States
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New Port Richey, Florida, 34652, United States
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Orlando, Florida, 32806, United States
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West Palm Beach, Florida, 33409, United States
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Winter Garden, Florida, 34787, United States
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Winter Park, Florida, 32708, United States
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Topeka, Kansas, 66606, United States
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Shreveport, Louisiana, 71103, United States
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Baltimore, Maryland, 21215, United States
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Hagerstown, Maryland, 21742, United States
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Silver Spring, Maryland, 20901, United States
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Boston, Massachusetts, 02115, United States
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Detroit, Michigan, 48235, United States
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Kalamazoo, Michigan, 49008, United States
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Paw Paw, Michigan, 49079, United States
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Jackson, Mississippi, 39202, United States
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St Louis, Missouri, 63141, United States
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Lebanon, New Hampshire, 03756, United States
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Elizabeth, New Jersey, 07202, United States
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Lumberton, New Jersey, 08048, United States
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Bayside, New York, 11358, United States
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Brooklyn, New York, 11214, United States
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New York, New York, 10021, United States
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Troy, New York, 12180, United States
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Asheboro, North Carolina, 27203, United States
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Charlotte, North Carolina, 28207, United States
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Durham, North Carolina, 27713, United States
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Fayetteville, North Carolina, 28304, United States
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Greensboro, North Carolina, 27408, United States
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High Point, North Carolina, 27262, United States
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Mooresville, North Carolina, 28117, United States
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Raleigh, North Carolina, 27609, United States
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Salisbury, North Carolina, 28144, United States
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Wilmington, North Carolina, 28401, United States
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Fargo, North Dakota, 58103, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44122, United States
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Columbus, Ohio, 43215, United States
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Dayton, Ohio, 45440, United States
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Zanesville, Ohio, 43701, United States
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Tulsa, Oklahoma, 74104, United States
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Portland, Oregon, 97210, United States
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Portland, Oregon, 97225, United States
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Lancaster, Pennsylvania, 17601, United States
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Germantown, Tennessee, 38138, United States
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Jackson, Tennessee, 38301, United States
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Johnson City, Tennessee, 37604, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78705, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77090, United States
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Pasadena, Texas, 77504, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Tyler, Texas, 75701, United States
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Ogden, Utah, 84405, United States
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West Jordan, Utah, 84088, United States
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Chesapeake, Virginia, 23320, United States
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Lynchburg, Virginia, 24502, United States
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Bellevue, Washington, 98004, United States
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Spokane, Washington, 99216, United States
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West Bend, Wisconsin, 53095, United States
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St. John's, Newfoundland and Labrador, A1E 2E2, Canada
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Corunna, Ontario, N0N 1G0, Canada
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Hamilton, Ontario, L8M 1K7, Canada
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Hamilton, Ontario, L8N 3Z5, Canada
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Hamilton, Ontario, L9N 4A6, Canada
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London, Ontario, N6A 5R8, Canada
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London, Ontario, N6A 5R9, Canada
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Newmarket, Ontario, L3Y 5G8, Canada
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Niagara Falls, Ontario, L2G 1J4, Canada
Unknown Facility
Sarnia, Ontario, N7T 4X3, Canada
Related Publications (3)
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.
PMID: 21208106RESULTLacy BE, Chang L, Rao SSC, Heimanson Z, Sayuk GS. Rifaximin Treatment for Individual and Multiple Symptoms of Irritable Bowel Syndrome With Diarrhea: An Analysis Using New End Points. Clin Ther. 2023 Mar;45(3):198-209. doi: 10.1016/j.clinthera.2023.01.010. Epub 2023 Mar 14.
PMID: 36922331DERIVEDSchoenfeld 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.
PMID: 24697851DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Sorscher
- Organization
- Salix
Study Officials
- STUDY DIRECTOR
Enoch Bortey
Bausch Health Americas, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2008
First Posted
August 11, 2008
Study Start
July 1, 2008
Primary Completion
August 1, 2009
Study Completion
September 1, 2009
Last Updated
November 29, 2019
Results First Posted
July 28, 2014
Record last verified: 2019-11