A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Enrolling by invitation · Phase 3

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT04880876

Run by

AbbVie

People needed

124

Starts

2021-08-13

Expected to finish

2032-12-01

Last updated by the study team

2025-07-17

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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