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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-13

Study Completion Date

2032-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Open Label 6-11 years of age: Eluxadoline 50mg

Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day.

Group Type EXPERIMENTAL

25mg Eluxadoline

Intervention Type DRUG

Oral Tablets

Open Label 12-17 years of age: Eluxadoline 100 mg

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.

Group Type EXPERIMENTAL

25mg Eluxadoline

Intervention Type DRUG

Oral Tablets

100mg Eluxadoline

Intervention Type DRUG

Oral Tablets

Double Blind 6-11 years of age: Eluxadoline 25mg

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

Group Type EXPERIMENTAL

25mg Eluxadoline

Intervention Type DRUG

Oral Tablets

Double Blind 6-11 years of age: Eluxadoline 50mg

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

Group Type EXPERIMENTAL

25mg Eluxadoline

Intervention Type DRUG

Oral Tablets

Double Blind 12-17 years of age: Eluxadoline 25mg

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

Group Type EXPERIMENTAL

25mg Eluxadoline

Intervention Type DRUG

Oral Tablets

Double Blind 12-17 years of age: Eluxadoline 50mg

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

Group Type EXPERIMENTAL

25mg Eluxadoline

Intervention Type DRUG

Oral Tablets

Double Blind 12-17 years of age: Eluxadoline 100mg

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

Group Type EXPERIMENTAL

25mg Eluxadoline

Intervention Type DRUG

Oral Tablets

Interventions

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25mg Eluxadoline

Oral Tablets

Intervention Type DRUG

100mg Eluxadoline

Oral Tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No