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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Rifaximin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 525
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Scottsdale
    • Tempe, Arizona, United States, 85282
      • Premeire Pharmaceutical Research
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
    • Irvine, California, United States, 92618
      • Lovelace Scientific Resources
    • Los Angeles, California, United States, 90045
      • West Gastroenterology Medical Group
    • Los Angeles, California, United States, 90067
      • Beverly Hills Gastroenterology
    • San Diego, California, United States, 92123
      • Medical Associates Research Group
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Gastroenterology Associates of Fairfield County
    • Bristol, Connecticut, United States, 06010-0977
      • Connecticut Gastroenterology Institute
    • Torrington, Connecticut, United States, 06790
      • Litchfield County Gastroenterology Associates, LLC
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • DeLand, Florida, United States, 32720
      • University Clinical Research
    • Hialeah, Florida, United States, 33016
      • Research Consultants Group
    • Jacksonville, Florida, United States, 32256
      • Borland-Groover Clinic
    • Miami, Florida, United States, 33173
      • Miami Research Associates
    • Palm Harbor, Florida, United States, 34684
      • Advanced Gastroenterology Associates
    • Winter Park, Florida, United States, 32789
      • Shafran Gastroenterology
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic
  • Illinois
    • Rockford, Illinois, United States, 61107
      • Rockford Gastroenterology
  • Indiana
    • Anderson, Indiana, United States, 46016
      • Community Clinical Research Center
    • Indianapolis, Indiana, United States, 46237
      • Indianapolis Gastroenterology Research Foundation
  • Iowa
    • Davenport, Iowa, United States, 52807
      • Gastrointestinal Clinic of Quad Citites
  • Kansas
    • Kansas City, Kansas, United States, 66160-7350
      • University of Kansas Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Digestive Disorders Associates
    • Chevy Chase, Maryland, United States, 20815
      • Chevy Chase Clinical Research
    • Hagerstown, Maryland, United States, 21740
      • Washington County Hospital
    • Severna Park, Maryland, United States, 21146
      • Maryland Clinical Trials
    • Silver Springs, Maryland, United States, 20901
      • Capital Gastroenterology Consultants, PA
  • Massachusetts
    • Braintree, Massachusetts, United States, 02184
      • Coastal Research Associates
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Henry Ford Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Gastrointestinal Associates, PA
    • Tupelo, Mississippi, United States, 38801
      • Digestive Health Specialists, PA
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Gastroenterology and Hepatology
    • Mexico, Missouri, United States, 65265
      • Center for Digestive & Liver Diseases, Inc.
    • Saint Louis, Missouri, United States, 63141
      • Specialist in Gastroenterology
  • Nebraska
    • Lincoln, Nebraska, United States, 68503
      • Gastroenterology Specialities
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research
    • Lake Success, New York, United States, 11042
      • New York Center for Clinical Research
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology Associates
    • Chapel Hill, North Carolina, United States, 27579
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Gastroenterology & Hepatology
    • Greensboro, North Carolina, United States, 27408
      • Vital re:Search
    • Greenville, North Carolina, United States, 27834
      • Carolina Research
    • High Point, North Carolina, United States, 27262
      • Bethany Medical Center
    • Jacksonville, North Carolina, United States, 28546
      • East Carolina Gastroenterology
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Rocky Mount, North Carolina, United States, 27804
    • Wilmington, North Carolina, United States, 28401
      • Hanover Medical Specialists, PA
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research
    • Cincinnati, Ohio, United States, 45220
      • Digestive Health Network
    • Dayton, Ohio, United States, 45440
      • GI & Liver Diseases Consultants
    • Kettering, Ohio, United States, 45429
      • Wells Institute for Health Awareness
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Foundation for Digestive Research
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Health Specialists, PA
  • Oregon
    • Portland, Oregon, United States, 97225
      • West Hills Gastroenterology Associates, PC
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Columbia Gastroenterology Associates
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • ClinSearch
    • Jackson, Tennessee, United States, 38305
      • Regional Research Institute
    • Kingsport, Tennessee, United States, 37660
      • Holston Valley Physicians
  • Texas
    • Austin, Texas, United States, 78745
      • Austin Gastroenterology
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
    • Salt Lake City, Utah, United States, 84132
      • University of Utah School of Medicine
  • Virginia
    • Danville, Virginia, United States, 24541
      • Internal Medicine Associates
  • Washington
    • Bellevue, Washington, United States, 98004
      • Northwest Gastroenterology Associates
    • Redmond, Washington, United States, 98052
      • North Pacific Clinical Research
    • Spokane, Washington, United States, 99204
      • Spokane Digestive Disease Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: December 22, 2005
• First Submitted That Met QC Criteria: December 22, 2005
• First Posted (Estimate): December 23, 2005

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Irritable bowel syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin
• Other Study ID Numbers: RFIB2001