Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Efficacy and Safety of Three Different Doses (275, 550 AND 1100 MG) of Rifaximin Administered BID For Either Two or Four Weeks in The Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
1 other identifier
interventional
525
1 country
67
Brief Summary
This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550 mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an additional two weeks of placebo for a total of 4 weeks of treatment. A fifth group of subjects will receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully respond to treatment at the end of the 28-day Treatment Phase will be followed in a Post-treatment Phase that includes study visits during Weeks 6, 8, 12 and 16. Subjects who relapse during the Post-treatment Phase will be discontinued from the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2005
Typical duration for phase_2
67 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
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedNovember 25, 2019
November 1, 2019
1.7 years
December 22, 2005
November 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective of this trial is to evaluate the efficacy of a 14-day course of oral rifaximin at 550 mg BID versus placebo in providing adequate relief from Diarrhea-associated IBS (DIBS) symptoms.
Secondary Outcomes (3)
To evaluate the dose-response relationship of placebo administered for 28 days and rifaximin administered at 275 mg BID, 550 mg BID, or 1100 mg BID for 14 days;
to evaluate the efficacy of 550 mg BID for 4 weeks to determine if there are any differences when treatment is extended for an additional 2-week period when compared to a similar dosing regimen for 2 weeks;
to evaluate the durability of response over a 12-week Post-treatment Phase in subjects with DIBS who achieved a response during the acute Treatment Phase of the study.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subject 18 years of age or older.
- Irritable bowel syndrome confirmed by the Rome II Criteria
- Lower endoscopic examination that demonstrates normal colonic anatomy
You may not qualify if:
- Subject has exclusively constipation-predominant IBS (CIBS) that is characterized by \< 3 bowel movements/week or hard and lumpy stools.
- Subject has alternating IBS, but is currently presenting with constipation associated IBS symptoms.
- Subject has had adequate control of their DIBS and their symptom of bloating the week preceding the screening visit or at the time of randomization. Bloating includes the following symptoms: abdominal fullness, bloating, gas, or swelling.
- Subjects has a positive stool culture for O \& P (ovum and parasite) and/or Clostridium difficile
- Subject has failed to record 2 negative weekly global assessments during the past 10 days prior to randomization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Premeire Pharmaceutical Research
Tempe, Arizona, 85282, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Lovelace Scientific Resources
Irvine, California, 92618, United States
West Gastroenterology Medical Group
Los Angeles, California, 90045, United States
Beverly Hills Gastroenterology
Los Angeles, California, 90067, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606, United States
Connecticut Gastroenterology Institute
Bristol, Connecticut, 06010-0977, United States
Litchfield County Gastroenterology Associates, LLC
Torrington, Connecticut, 06790, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
University Clinical Research
DeLand, Florida, 32720, United States
Research Consultants Group
Hialeah, Florida, 33016, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Miami Research Associates
Miami, Florida, 33173, United States
Advanced Gastroenterology Associates
Palm Harbor, Florida, 34684, United States
Shafran Gastroenterology
Winter Park, Florida, 32789, United States
Florida Medical Clinic
Zephyrhills, Florida, 33542, United States
Rockford Gastroenterology
Rockford, Illinois, 61107, United States
Community Clinical Research Center
Anderson, Indiana, 46016, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
Gastrointestinal Clinic of Quad Citites
Davenport, Iowa, 52807, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7350, United States
Digestive Disorders Associates
Annapolis, Maryland, 21401, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Washington County Hospital
Hagerstown, Maryland, 21740, United States
Maryland Clinical Trials
Severna Park, Maryland, 21146, United States
Capital Gastroenterology Consultants, PA
Silver Springs, Maryland, 20901, United States
Coastal Research Associates
Braintree, Massachusetts, 02184, United States
Henry Ford Hospital
Chesterfield, Michigan, 48047, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202, United States
Digestive Health Specialists, PA
Tupelo, Mississippi, 38801, United States
Gastroenterology and Hepatology
Kansas City, Missouri, 64131, United States
Center for Digestive & Liver Diseases, Inc.
Mexico, Missouri, 65265, United States
Specialist in Gastroenterology
St Louis, Missouri, 63141, United States
Gastroenterology Specialities
Lincoln, Nebraska, 68503, United States
Long Island Clinical Research
Great Neck, New York, 11021, United States
New York Center for Clinical Research
Lake Success, New York, 11042, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
University of North Carolina
Chapel Hill, North Carolina, 27579, United States
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, 28207, United States
Vital re:Search
Greensboro, North Carolina, 27408, United States
Carolina Research
Greenville, North Carolina, 27834, United States
Bethany Medical Center
High Point, North Carolina, 27262, United States
East Carolina Gastroenterology
Jacksonville, North Carolina, 28546, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Unknown Facility
Rocky Mount, North Carolina, 27804, United States
Hanover Medical Specialists, PA
Wilmington, North Carolina, 28401, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Digestive Health Network
Cincinnati, Ohio, 45220, United States
GI & Liver Diseases Consultants
Dayton, Ohio, 45440, United States
Wells Institute for Health Awareness
Kettering, Ohio, 45429, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104, United States
Digestive Health Specialists, PA
Oklahoma City, Oklahoma, 73112, United States
West Hills Gastroenterology Associates, PC
Portland, Oregon, 97225, United States
Columbia Gastroenterology Associates
Columbia, South Carolina, 29203, United States
ClinSearch
Chattanooga, Tennessee, 37404, United States
Regional Research Institute
Jackson, Tennessee, 38305, United States
Holston Valley Physicians
Kingsport, Tennessee, 37660, United States
Austin Gastroenterology
Austin, Texas, 78745, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Internal Medicine Associates
Danville, Virginia, 24541, United States
Northwest Gastroenterology Associates
Bellevue, Washington, 98004, United States
North Pacific Clinical Research
Redmond, Washington, 98052, United States
Spokane Digestive Disease Center
Spokane, Washington, 99204, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
Related Publications (1)
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.
PMID: 24697851DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 23, 2005
Study Start
December 1, 2005
Primary Completion
August 1, 2007
Study Completion
September 1, 2008
Last Updated
November 25, 2019
Record last verified: 2019-11