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

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269412
• Other study ID #: RFIB2001
• Status: Completed
• Phase: Phase 2
• Start date: December 2005
• Est. completion date: September 2008

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: September 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Rifaximin

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Community Clinical Research Center	Anderson	Indiana
United States	Digestive Disorders Associates	Annapolis	Maryland
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	Austin Gastroenterology	Austin	Texas
United States	Northwest Gastroenterology Associates	Bellevue	Washington
United States	Coastal Research Associates	Braintree	Massachusetts
United States	Gastroenterology Associates of Fairfield County	Bridgeport	Connecticut
United States	Connecticut Gastroenterology Institute	Bristol	Connecticut
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Charlotte Gastroenterology & Hepatology	Charlotte	North Carolina
United States	ClinSearch	Chattanooga	Tennessee
United States	Henry Ford Hospital	Chesterfield	Michigan
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Digestive Health Network	Cincinnati	Ohio
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Columbia Gastroenterology Associates	Columbia	South Carolina
United States	Internal Medicine Associates	Danville	Virginia
United States	Gastrointestinal Clinic of Quad Citites	Davenport	Iowa
United States	GI & Liver Diseases Consultants	Dayton	Ohio
United States	University Clinical Research	DeLand	Florida
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	Washington County Hospital	Hagerstown	Maryland
United States	Research Consultants Group	Hialeah	Florida
United States	Bethany Medical Center	High Point	North Carolina
United States	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana
United States	Lovelace Scientific Resources	Irvine	California
United States	Gastrointestinal Associates, PA	Jackson	Mississippi
United States	Regional Research Institute	Jackson	Tennessee
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	East Carolina Gastroenterology	Jacksonville	North Carolina
United States	Gastroenterology and Hepatology	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Wells Institute for Health Awareness	Kettering	Ohio
United States	Holston Valley Physicians	Kingsport	Tennessee
United States	New York Center for Clinical Research	Lake Success	New York
United States	Gastroenterology Specialities	Lincoln	Nebraska
United States	Beverly Hills Gastroenterology	Los Angeles	California
United States	West Gastroenterology Medical Group	Los Angeles	California
United States	Center for Digestive & Liver Diseases, Inc.	Mexico	Missouri
United States	Miami Research Associates	Miami	Florida
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Advanced Research Institute	Ogden	Utah
United States	Digestive Health Specialists, PA	Oklahoma City	Oklahoma
United States	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma
United States	Advanced Gastroenterology Associates	Palm Harbor	Florida
United States	West Hills Gastroenterology Associates, PC	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina
United States	North Pacific Clinical Research	Redmond	Washington
United States	Rockford Gastroenterology	Rockford	Illinois
United States	Specialist in Gastroenterology	Saint Louis	Missouri
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	Medical Associates Research Group	San Diego	California
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Maryland Clinical Trials	Severna Park	Maryland
United States	Capital Gastroenterology Consultants, PA	Silver Springs	Maryland
United States	Spokane Digestive Disease Center	Spokane	Washington
United States	Premeire Pharmaceutical Research	Tempe	Arizona
United States	Litchfield County Gastroenterology Associates, LLC	Torrington	Connecticut
United States	Digestive Health Specialists, PA	Tupelo	Mississippi
United States	Hanover Medical Specialists, PA	Wilmington	North Carolina
United States	Shafran Gastroenterology	Winter Park	Florida
United States	Florida Medical Clinic	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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;
Secondary	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;
Secondary	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.