NCT02959983

Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 346 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome With Diarrhea

Interventions

Type	Name	Description
DRUG	Eluxadoline	Eluxadoline 100 mg oral tablets BID with food.
DRUG	Placebo	Placebo matching eluxadoline oral tablets BID with food.

Timeline

• Start date: 2016-10-25
• Primary completion: 2018-01-22
• Completion: 2018-01-22
• First posted: 2016-11-09
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

83 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study