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

Launched by ABBVIE · May 5, 2021

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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 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