Clinical trial NCT00269412: Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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