At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 346 enrolled
Drug / intervention
Eluxadoline +1 moredrug
Likely dose
Eluxadoline 100 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 Phase 4 Multicenter, Multinational, Prospective, Randomized, Placebo-Controlled, Double-Blinded Parallel Group Study to Assess Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) in Patients Who Report Inadequate Control of IBS-D Symptoms With Prior Loperamide Use (RELIEF)
In Brief
A Phase 4 clinical trial evaluating Eluxadoline and Placebo for Irritable Bowel Syndrome With Diarrhea. Completed, enrolled 346 participants across 83 sites in 2 countries.
Detailed Summary
This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to provide control of their IBS-D symptoms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome With Diarrhea
CountriesCanada, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedNov 2016
Primary CompletionJan 2018
TodayJul 2026
First PostedNov 9, 2016
Enrollment StartOct 25, 2016
Primary CompletionJan 22, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.6 years ago
Interventions
Eluxadolinedrug
Eluxadoline 100 mg oral tablets BID with food.
Placebodrug
Placebo matching eluxadoline oral tablets BID with food.