At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,583 enrolled
Drug / intervention
open-label rifaximin +2 moredrug
Likely dose
open-label rifaximin 550 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects With Irritable Bowel Syndrome With Diarrhea (IBS-D)
In Brief
A Phase 3 clinical trial evaluating open-label rifaximin, double-blind placebo, and 1 other intervention for Irritable Bowel Syndrome With Diarrhea. Completed, enrolled 2,583 participants across 296 sites in 3 countries.
Detailed Summary
This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550 mg three times a day in patients with IBS with diarrhea who respond to initial treatment of rifaximin 550 mg three times a day.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome With Diarrhea
CountriesGermany, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedMar 2012
Primary CompletionJun 2014
TodayJul 2026
First PostedMar 2, 2012
Enrollment StartFeb 1, 2012
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.3 years ago
Interventions
open-label rifaximindrug
550 mg three times a day (open-label)
double-blind placebodrug
3 times a day (double-blind)
double-blind rifaximindrug
550 mg three times a day (double-blind)