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)
AbbVie
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.
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures. * Participant is a male or female outpatient, 6 to 17 years of age inclusive, at the time the participant provides assent for the study and parent/guardian/LAR has provided signed consent. * Participant is able to read and understand the assessments in the eDiary. If the participant is 6 to 11 years of age and does not meet this criterion, the interviewer-administered version of the eDiary mus…
Interventions
- DrugEluxadoline
Oral tablets
- DrugPlacebo
Oral tablets
Locations (46)
- HealthStar Research of Hot Springs PLLC /ID# 234609Hot Springs, Arkansas
- Applied Research Center of Arkansas /ID# 238070Little Rock, Arkansas
- Kindred Medical Institute, LLC /ID# 237368Corona, California
- Duplicate_VVCRD Research /ID# 234606Garden Grove, California
- Duplicate_Center for Clinical Trials LLC /ID# 234630Paramount, California
- Sunrise Research Institute /ID# 237382Miami, Florida