Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
6–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 be 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
Clareo Health | A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
