Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome
- Registration Number
- NCT00269412
- Lead Sponsor
- Bausch Health Americas, Inc.
- 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.
- Detailed Description
While IBS is one of the most common chronic medical conditions the etiology of IBS is unknown. Although not a life-threatening illness, IBS is considered to be a serious condition that has a substantial impact on a subject's day-to-day function. IBS is characterized by abdominal pain and altered bowel habits, including diarrhea, constipation, or alternating diarrhea and constipation. Symptoms are typically intermittent but may be continuous.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 525
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (65)
Gastroenterology Associates of Fairfield County
🇺🇸Bridgeport, Connecticut, United States
Litchfield County Gastroenterology Associates, LLC
🇺🇸Torrington, Connecticut, United States
University Clinical Research
🇺🇸DeLand, Florida, United States
Research Consultants Group
🇺🇸Hialeah, Florida, United States
Florida Medical Clinic
🇺🇸Zephyrhills, Florida, United States
Capital Gastroenterology Consultants, PA
🇺🇸Silver Springs, Maryland, United States
Henry Ford Hospital
🇺🇸Chesterfield, Michigan, United States
Gastrointestinal Associates, PA
🇺🇸Jackson, Mississippi, United States
Maryland Clinical Trials
🇺🇸Severna Park, Maryland, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
East Carolina Gastroenterology
🇺🇸Jacksonville, North Carolina, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Premeire Pharmaceutical Research
🇺🇸Tempe, Arizona, United States
Specialist in Gastroenterology
🇺🇸Saint Louis, Missouri, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Lovelace Scientific Resources
🇺🇸Irvine, California, United States
West Gastroenterology Medical Group
🇺🇸Los Angeles, California, United States
Connecticut Gastroenterology Institute
🇺🇸Bristol, Connecticut, United States
Beverly Hills Gastroenterology
🇺🇸Los Angeles, California, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Advanced Gastroenterology Associates
🇺🇸Palm Harbor, Florida, United States
Shafran Gastroenterology
🇺🇸Winter Park, Florida, United States
Rockford Gastroenterology
🇺🇸Rockford, Illinois, United States
Community Clinical Research Center
🇺🇸Anderson, Indiana, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
Gastrointestinal Clinic of Quad Citites
🇺🇸Davenport, Iowa, United States
Digestive Disorders Associates
🇺🇸Annapolis, Maryland, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Washington County Hospital
🇺🇸Hagerstown, Maryland, United States
Coastal Research Associates
🇺🇸Braintree, Massachusetts, United States
Center for Digestive & Liver Diseases, Inc.
🇺🇸Mexico, Missouri, United States
Charlotte Gastroenterology & Hepatology
🇺🇸Charlotte, North Carolina, United States
Hanover Medical Specialists, PA
🇺🇸Wilmington, North Carolina, United States
Bethany Medical Center
🇺🇸High Point, North Carolina, United States
GI & Liver Diseases Consultants
🇺🇸Dayton, Ohio, United States
Wells Institute for Health Awareness
🇺🇸Kettering, Ohio, United States
Columbia Gastroenterology Associates
🇺🇸Columbia, South Carolina, United States
Internal Medicine Associates
🇺🇸Danville, Virginia, United States
Northwest Gastroenterology Associates
🇺🇸Bellevue, Washington, United States
North Pacific Clinical Research
🇺🇸Redmond, Washington, United States
Spokane Digestive Disease Center
🇺🇸Spokane, Washington, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Digestive Health Specialists, PA
🇺🇸Oklahoma City, Oklahoma, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Oklahoma Foundation for Digestive Research
🇺🇸Oklahoma City, Oklahoma, United States
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
West Hills Gastroenterology Associates, PC
🇺🇸Portland, Oregon, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Long Island Clinical Research
🇺🇸Great Neck, New York, United States
Vital re:Search
🇺🇸Greensboro, North Carolina, United States
Carolina Research
🇺🇸Greenville, North Carolina, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Digestive Health Network
🇺🇸Cincinnati, Ohio, United States
Asheville Gastroenterology Associates
🇺🇸Asheville, North Carolina, United States
New York Center for Clinical Research
🇺🇸Lake Success, New York, United States
Gastroenterology Specialities
🇺🇸Lincoln, Nebraska, United States
Holston Valley Physicians
🇺🇸Kingsport, Tennessee, United States
Regional Research Institute
🇺🇸Jackson, Tennessee, United States
Gastroenterology and Hepatology
🇺🇸Kansas City, Missouri, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Austin Gastroenterology
🇺🇸Austin, Texas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States