NCT01553747

Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,146 (actual)
• Sponsor: Furiex Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Eluxadoline	Oral tablets twice daily
DRUG	Placebo	Oral tablets twice daily

Timeline

• Start date: 2012-05-29
• Primary completion: 2014-01-09
• Completion: 2014-01-09
• First posted: 2012-03-14
• Last updated: 2018-07-30
• Results posted: 2018-07-30

Locations

253 sites across 4 countries: United States, Canada, Puerto Rico, United Kingdom