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

• Status: Recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Eluxadoline

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 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