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

NCT ID: NCT00269412

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-09-30

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Rifaximin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subject 18 years of age or older.

2. Irritable bowel syndrome confirmed by the Rome II Criteria

3. Lower endoscopic examination that demonstrates normal colonic anatomy

Exclusion Criteria

1. Subject has exclusively constipation-predominant IBS (CIBS) that is characterized by < 3 bowel movements/week or hard and lumpy stools.

2. Subject has alternating IBS, but is currently presenting with constipation associated IBS symptoms.

3. 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.

4. Subjects has a positive stool culture for O & P (ovum and parasite) and/or Clostridium difficile

5. Subject has failed to record 2 negative weekly global assessments during the past 10 days prior to randomization.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Locations

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

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

Washington County Hospital

Hagerstown, Maryland, United States

Maryland Clinical Trials

Severna Park, Maryland, United States

Capital Gastroenterology Consultants, PA

Silver Springs, Maryland, United States

Coastal Research Associates

Braintree, Massachusetts, United States

Henry Ford Hospital

Chesterfield, Michigan, United States

Gastrointestinal Associates, PA

Jackson, Mississippi, United States

Digestive Health Specialists, PA

Tupelo, Mississippi, United States

Gastroenterology and Hepatology

Kansas City, Missouri, United States

Center for Digestive & Liver Diseases, Inc.

Mexico, Missouri, United States

Specialist in Gastroenterology

St Louis, Missouri, United States

Gastroenterology Specialities

Lincoln, Nebraska, United States

Long Island Clinical Research

Great Neck, New York, United States

New York Center for Clinical Research

Lake Success, New York, United States

Asheville Gastroenterology Associates

Asheville, North Carolina, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Charlotte Gastroenterology & Hepatology

Charlotte, North Carolina, United States

Vital re:Search

Greensboro, North Carolina, United States

Carolina Research

Greenville, North Carolina, United States

Bethany Medical Center

High Point, North Carolina, United States

East Carolina Gastroenterology

Jacksonville, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Rocky Mount, North Carolina, United States

Hanover Medical Specialists, PA

Wilmington, North Carolina, United States

Consultants for Clinical Research

Cincinnati, Ohio, United States

Digestive Health Network

Cincinnati, Ohio, United States

GI & Liver Diseases Consultants

Dayton, Ohio, United States

Wells Institute for Health Awareness

Kettering, Ohio, United States

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Digestive Health Specialists, PA

Oklahoma City, Oklahoma, United States

West Hills Gastroenterology Associates, PC

Portland, Oregon, United States

Columbia Gastroenterology Associates

Columbia, South Carolina, United States

ClinSearch

Chattanooga, Tennessee, United States

Regional Research Institute

Jackson, Tennessee, United States

Holston Valley Physicians

Kingsport, Tennessee, United States

Austin Gastroenterology

Austin, Texas, United States

Advanced Research Institute

Ogden, Utah, United States

University of Utah School of Medicine

Salt Lake City, Utah, 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

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24697851 (View on PubMed)

Other Identifiers

RFIB2001

Identifier Type: -

Identifier Source: org_study_id