Clinical trial NCT00731679: Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin 550 mg TID in the Treatment of Subjects With Non-Constipation Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Constipation Irritable Bowel Syndrome
Keywords: IBS
Abdominal pain
Bloating
Diarrhea
Rifaximin
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 623
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: To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.


Eligibility criteria: Inclusion Criteria:

* Confirmed IBS diagnosis per Rome II for diagnosis of IBS.
* Colonoscopy within 2 years as part of IBS diagnostic evaluation.
* Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency.

Exclusion Criteria:

* Symptoms of constipation.
* History of other gastrointestinal diseases.
* Type 1 or 2 diabetes.
* Lactose intolerance not controlled by lactose-free diet.

Primary outcomes:
measure: Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hueytown
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Sierra Vista
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Sherwood
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Murrieta
country: United States
state: California
city: San Diego
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Torrington
country: United States
state: Connecticut
city: Altamonte Springs
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Winter Garden
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Topeka
country: United States
state: Kansas
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Paw Paw
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Elizabeth
country: United States
state: New Jersey
city: Lumberton
country: United States
state: New Jersey
city: Bayside
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: Troy
country: United States
state: New York
city: Asheboro
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Mooresville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Zanesville
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Lancaster
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Pasadena
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Chesapeake
country: United States
state: Virginia
city: Lynchburg
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: West Bend
country: United States
state: Wisconsin
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Corunna
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Niagara Falls
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Enoch Bortey
role: STUDY_DIRECTOR
References:
citation: Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.
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.