Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome with Diarrhea IBSD IBS-D Irritable Bowel Syndrome Pediatric
Brief 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.
Interventions
DRUG25mg Eluxadoline
Oral Tablets
DRUG100mg Eluxadoline
Oral Tablets
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events | 52 weeks |
| Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator | 52 weeks |
| Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator | 52 weeks |
| Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator | 52 weeks |
| Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline | 52 weeks |
| Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline | 52 weeks |
Countries
United States
Outcome results
None listed