NCT03339128

Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Pediatric Participants (Age 6 to 17 Years) With Irritable Bowel Syndrome With Diarrhea (IBS-D)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Eluxadoline	Oral tablets
DRUG	Placebo	Oral tablets

Timeline

• Start date: 2017-11-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2017-11-13
• Last updated: 2025-09-19

Locations

46 sites across 9 countries: United States, Bulgaria, Canada, Germany, Hungary, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study