Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome

Completed · Phase 2

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT00269412

Run by

Bausch Health Americas, Inc.

People needed

525

Starts

2005-12-01

Expected to finish

2008-09-01

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Premeire Pharmaceutical Research — Tempe, 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
• Beverly Hills Gastroenterology — Los Angeles, California, United States
• Medical Associates Research Group — San Diego, California, United States
• Gastroenterology Associates of Fairfield County — Bridgeport, Connecticut, United States
• Connecticut Gastroenterology Institute — Bristol, Connecticut, United States
• Litchfield County Gastroenterology Associates, LLC — Torrington, Connecticut, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• University Clinical Research — DeLand, Florida, United States
• Research Consultants Group — Hialeah, Florida, 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
• Florida Medical Clinic — Zephyrhills, 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
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Digestive Disorders Associates — Annapolis, Maryland, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.