A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Irritable Bowel Syndrome
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 2 arms for open-label (6 to 11-year-olds and 12 to 17-year-olds) 5 arms for double-blind (6 to 11-year-olds: 25 and 50 mg; 12 to 17-year-olds: 25, 50, and 100 mg)Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 17 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04880876
- Collaborators
- Not Provided
- Investigators
- Study Director: Taryn Weissman, MD Allergan