Trials / Enrolling By Invitation
Enrolling By InvitationNCT04880876
A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
- Status
- Enrolling By Invitation
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 25mg Eluxadoline | Oral Tablets |
| DRUG | 100mg Eluxadoline | Oral Tablets |
Timeline
- Start date
- 2021-08-13
- Primary completion
- 2032-12-01
- Completion
- 2032-12-01
- First posted
- 2021-05-11
- Last updated
- 2025-07-17
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04880876. Inclusion in this directory is not an endorsement.