A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Status and phase
Invitation-only
Phase 3
Conditions
Irritable Bowel Syndrome
Treatments
Drug: 25mg Eluxadoline
Drug: 100mg Eluxadoline
Details and patient eligibility
About
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.
Enrollment
124 estimated patients
Sex
All
Ages
6 to 17 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
124 participants in 7 patient groups
Open Label 6-11 years of age: Eluxadoline 50mg
Experimental group
Description:
Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day.
Treatment:
Drug: 25mg Eluxadoline
Open Label 12-17 years of age: Eluxadoline 100 mg
Experimental group
Description:
Eluxadoline one 100mg tablet, oral administration, twice daily with food. May use 25mg tablets to administer 100mg dose. Take at approximately the same time each day.
Treatment:
Drug: 100mg Eluxadoline
Drug: 25mg Eluxadoline
Double Blind 6-11 years of age: Eluxadoline 25mg
Experimental group
Description:
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Treatment:
Drug: 25mg Eluxadoline
Double Blind 6-11 years of age: Eluxadoline 50mg
Experimental group
Description:
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Treatment:
Drug: 25mg Eluxadoline
Double Blind 12-17 years of age: Eluxadoline 25mg
Experimental group
Description:
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Treatment:
Drug: 25mg Eluxadoline
Double Blind 12-17 years of age: Eluxadoline 50mg
Experimental group
Description:
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Treatment:
Drug: 25mg Eluxadoline
Double Blind 12-17 years of age: Eluxadoline 100mg
Experimental group
Description:
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Treatment:
Drug: 25mg Eluxadoline
Trial contacts and locations
4
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Data sourced from clinicaltrials.gov
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