Status:
ENROLLING_BY_INVITATION
A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Lead Sponsor:
AbbVie
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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 participant from performing any protocol assessments, or could confound study assessments.
- Participant has known allergies or hypersensitivity to opioids
- Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
- Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
- Participant has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
- Participant has a history of pancreatitis; structural diseases of the pancreas, known or suspected pancreatic duct obstruction
- Participant has a history of chronic or severe constipation, or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction
- Participant has renal impairment or an unstable hepatic, metabolic, or hematologic condition.
- Participant is a current regular alcohol drinker and/or binge drinker\*, and/or has a history of alcoholism, alcohol abuse (eg, binge-drinking\*), or alcohol addiction, and/or intends to consume alcohol during the study
Key Trial Info
Start Date :
August 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04880876
Start Date
August 13 2021
End Date
December 1 2032
Last Update
July 17 2025
Active Locations (6)
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1
Kindred Medical Institute, LLC /ID# 227595
Corona, California, United States, 92879
2
Valencia Medical & Research Center /ID# 246221
Miami, Florida, United States, 33165
3
Florida Research Center, Inc. /ID# 227597
Miami, Florida, United States, 33174
4
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600
Stockbridge, Georgia, United States, 30281