Clinical trial NCT00724126: 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: Diarrhea
Rifaximin
IBS
Abdominal pain
Bloating
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 637
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 criteria 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: Anniston
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Tempe
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Concord
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Lakewood
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Monterey
country: United States
state: California
city: Orange
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Carlos
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Bristol
country: United States
state: Connecticut
city: Hamden
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Boca Raton
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Elkhart
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Bowling Green
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Monroe
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Elkridge
country: United States
state: Maryland
city: Wellesley
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Wyoming
country: United States
state: Michigan
city: Mexico
country: United States
state: Missouri
city: Sicklerville
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Great Neck
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: North Massapequa
country: United States
state: New York
city: Pomona
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Boone
country: United States
state: North Carolina
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Downingtown
country: United States
state: Pennsylvania
city: Newtown
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sayre
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Franklin
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: El Paso
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lewisville
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Chesapeake
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
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.