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

Sponsor:	Salix Pharmaceuticals
Information provided by:	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00269412

Purpose

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.

Condition	Intervention	Phase
Irritable Bowel Syndrome	Drug: Rifaximin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Rifaximin

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	525
Study Start Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269412

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Locations

United States, Arizona
Premeire Pharmaceutical Research
Tempe, Arizona, United States, 85282
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
Medical Associates Research Group
San Diego, California, United States, 92123
Lovelace Scientific Resources
Irvine, California, United States, 92618
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Beverly Hills Gastroenterology
Los Angeles, California, United States, 90067
West Gastroenterology Medical Group
Los Angeles, California, United States, 90045
United States, Connecticut
Litchfield County Gastroenterology Associates, LLC
Torrington, Connecticut, United States, 06790
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States, 06606
Connecticut Gastroenterology Institute
Bristol, Connecticut, United States, 06010-0977
United States, Florida
Research Consultants Group
Hialeah, Florida, United States, 33016
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
Shafran Gastroenterology
Winter Park, Florida, United States, 32789
University Clinical Research
Deland, Florida, United States, 32720
Miami Research Associates
Miami, Florida, United States, 33173
Florida Medical Clinic
Zephyrhills, Florida, United States, 33542
Advanced Gastroenterology Associates
Palm Harbor, Florida, United States, 34684
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
United States, Illinois
Rockford Gastroenterology
Rockford, Illinois, United States, 61107
United States, Indiana
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States, 46237
Community Clinical Research Center
Anderson, Indiana, United States, 46016
United States, Iowa
Gastrointestinal Clinic of Quad Citites
Davenport, Iowa, United States, 52807
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7350
United States, Maryland
Maryland Clinical Trials
Severna Park, Maryland, United States, 21146
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Digestive Disorders Associates
Annapolis, Maryland, United States, 21401
Capital Gastroenterology Consultants, PA
Silver Springs, Maryland, United States, 20901
Washington County Hospital
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Coastal Research Associates
Braintree, Massachusetts, United States, 02184
United States, Michigan
Henry Ford Hospital
Chesterfield, Michigan, United States, 48047
United States, Mississippi
Gastrointestinal Associates, PA
Jackson, Mississippi, United States, 39202
Digestive Health Specialists, PA
Tupelo, Mississippi, United States, 38801
United States, Missouri
Center for Digestive & Liver Diseases, Inc.
Mexico, Missouri, United States, 65265
Specialist in Gastroenterology
St. Louis, Missouri, United States, 63141
Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
United States, Nebraska
Gastroenterology Specialities
Lincoln, Nebraska, United States, 68503
United States, New York
New York Center for Clinical Research
Lake Success, New York, United States, 11042
Long Island Clinical Research
Great Neck, New York, United States, 11021
United States, North Carolina
Asheville Gastroenterology Associates
Asheville, North Carolina, United States, 28801
East Carolina Gastroenterology
Jacksonville, North Carolina, United States, 28546

Rocky Mount, North Carolina, United States, 27804
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Hanover Medical Specialists, PA
Wilmington, North Carolina, United States, 28401
Bethany Medical Center
High Point, North Carolina, United States, 27262
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, United States, 28207
University of North Carolina
Chapel Hill, North Carolina, United States, 27579
Carolina Research
Greenville, North Carolina, United States, 27834
Vital re:Search
Greensboro, North Carolina, United States, 27408
United States, Ohio
GI & Liver Diseases Consultants
Dayton, Ohio, United States, 45440
Digestive Health Network
Cincinnati, Ohio, United States, 45220
Wells Institute for Health Awareness
Kettering, Ohio, United States, 45429
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Digestive Health Specialists, PA
Oklahoma City, Oklahoma, United States, 73112
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
West Hills Gastroenterology Associates, PC
Portland, Oregon, United States, 97225
United States, South Carolina
Columbia Gastroenterology Associates
Columbia, South Carolina, United States, 29203
United States, Tennessee
ClinSearch
Chattanooga, Tennessee, United States, 37404
Regional Research Institute
Jackson, Tennessee, United States, 38305
Holston Valley Physicians
Kingsport, Tennessee, United States, 37660
United States, Texas
Austin Gastroenterology
Austin, Texas, United States, 78745
United States, Utah
Advanced Research Institute
Ogden, Utah, United States, 84405
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Virginia
Internal Medicine Associates
Danville, Virginia, United States, 24541
United States, Washington
Spokane Digestive Disease Center
Spokane, Washington, United States, 99204
North Pacific Clinical Research
Redmond, Washington, United States, 98052
Northwest Gastroenterology Associates
Bellevue, Washington, United States, 98004
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Salix Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	RFIB2001
Study First Received:	December 22, 2005
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00269412 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:

Irritable bowel syndrome

Additional relevant MeSH terms:

Anti-Infective Agents
Disease
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Agents
Intestinal Diseases
Pharmacologic Actions

Digestive System Diseases
Pathologic Processes
Syndrome
Therapeutic Uses
Irritable Bowel Syndrome
Rifaximin
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on November 30, 2009