Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
NCT ID: NCT00724126
Last Updated: 2019-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
637 participants
INTERVENTIONAL
2008-07-31
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
NCT00731679
Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study
NCT01543178
Efficacy of Rifaximin With NAC in IBS-D
NCT06727422
Efficacy and Safety of Rifaximin With NAC in IBS-D
NCT04557215
The Effects of Rifaximin Therapy in Irritable Bowel Syndrome
NCT02009618
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Placebo
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.
Rifaximin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rifaximin
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* History of other gastrointestinal diseases.
* Type 1 or 2 diabetes.
* Lactose intolerance not controlled by lactose-free diet.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Enoch Bortey
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anniston, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Tempe, Arizona, United States
Anaheim, California, United States
Carmichael, California, United States
Chula Vista, California, United States
Concord, California, United States
Garden Grove, California, United States
Laguna Hills, California, United States
Lakewood, California, United States
Los Angeles, California, United States
Monterey, California, United States
Orange, California, United States
Roseville, California, United States
San Carlos, California, United States
San Francisco, California, United States
Bristol, Connecticut, United States
Hamden, Connecticut, United States
Newark, Delaware, United States
Boca Raton, Florida, United States
Hollywood, Florida, United States
Largo, Florida, United States
New Port Richey, Florida, United States
New Smyrna Beach, Florida, United States
Port Orange, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Elkhart, Indiana, United States
Kansas City, Kansas, United States
Topeka, Kansas, United States
Bowling Green, Kentucky, United States
Metairie, Louisiana, United States
Monroe, Louisiana, United States
Baltimore, Maryland, United States
Elkridge, Maryland, United States
Wellesley, Massachusetts, United States
Ann Arbor, Michigan, United States
Troy, Michigan, United States
Wyoming, Michigan, United States
Mexico, Missouri, United States
Sicklerville, New Jersey, United States
Voorhees Township, New Jersey, United States
Albuquerque, New Mexico, United States
Great Neck, New York, United States
Mineola, New York, United States
New York, New York, United States
North Massapequa, New York, United States
Pomona, New York, United States
Stony Brook, New York, United States
Boone, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Greensboro, North Carolina, United States
New Bern, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Downingtown, Pennsylvania, United States
Newtown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sayre, Pennsylvania, United States
Anderson, South Carolina, United States
Columbia, South Carolina, United States
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Franklin, Tennessee, United States
Germantown, Tennessee, United States
Jackson, Tennessee, United States
Kingsport, Tennessee, United States
El Paso, Texas, United States
Houston, Texas, United States
Lewisville, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Chesapeake, Virginia, United States
Fairfax, Virginia, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Lacy 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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RFIB3008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.