NCT00269412

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

Completed Phase 2 Last updated 21 November 2019

What this trial tests

Phase 2 trial testing Rifaximin in Irritable Bowel Syndrome in 525 participants. Completed in 1 September 2008.

Timeline

1 December 2005

Primary endpoint
1 August 2007

1 September 2008

Quick facts

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	525
Start date	1 December 2005
Primary completion	1 August 2007
Estimated completion	1 September 2008
Sites	67 locations across United States

Drugs / interventions tested

• Rifaximin (rifaximin) — full drug profile →

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Bausch Health Americas, Inc. — full company profile →

Who can join

18 and older, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double-blind, placebo-controlled trials.
   Schoenfeld P, Pimentel M, Chang L, Lembo A, et al · · 2014 · cited 79× · PMID 24697851 · DOI 10.1111/apt.12735