A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Key facts
- Where
- Corona, Miami, Oklahoma City, Pittsburgh, and Stockbridge, United StatesSee the 6 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT04880876, who can take part
Where in United States
- Kindred Medical Institute, LLC /ID# 227595Corona, United StatesNo longer taking part
- Florida Research Center, Inc. /ID# 227597Miami, United StatesNo longer taking part
- Valencia Medical & Research Center /ID# 246221Miami, United StatesNo longer taking part
- IPS Research Company /ID# 227594Oklahoma City, United StatesNo longer taking part
- Preferred Primary Care Physicians, Inc. /ID# 227596Pittsburgh, United StatesNo longer taking part
- Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600Stockbridge, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AbbVie
- Trial code
- NCT04880876
- Record updated
- 17 July 2025
- Original description
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.Read full original descriptionShow less
A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
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.
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 known allergies or hypersensitivity to opioids; 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; 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; 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).