A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

AbbVie

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.

Eligibility

Age range: 6–17 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: Inclusion Criteria: * Male or female participants must be 6 to 17 years of age (inclusive) * Participants must have completed study intervention in their lead-in study Exclusion Criteria: * Participant has an unresolved AE or a clinically significant finding on a physical examination, vital sign assessment, or neurological assessment along with an ECG or clinical laboratory tests (if results are available by the time of enrollment) that; in the opinion of the investigator, could represent a safety concern or a condition that would be exclusionary, could prevent the part…

Locations (6)

Kindred Medical Institute, LLC /ID# 227595
Corona, California
Valencia Medical & Research Center /ID# 246221
Miami, Florida
Florida Research Center, Inc. /ID# 227597
Miami, Florida
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600
Stockbridge, Georgia
IPS Research Company /ID# 227594
Oklahoma City, Oklahoma
Preferred Primary Care Physicians, Inc. /ID# 227596
Pittsburgh, Pennsylvania

Summary

Eligibility

Interventions

Locations (6)