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

Study Overview
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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.

Official Title
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A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: 25mg Eluxadoline
* Drug: 100mg Eluxadoline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label 6-11 years of age: Eluxadoline 50mg<br>Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day. | Drug: 25mg Eluxadoline<br>* Oral Tablets<br>|
| Experimental: Open Label 12-17 years of age: Eluxadoline 100 mg<br>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. | Drug: 25mg Eluxadoline<br>* Oral Tablets<br>Drug: 100mg Eluxadoline<br>* Oral Tablets<br>|
| Experimental: Double Blind 6-11 years of age: Eluxadoline 25mg<br>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 | Drug: 25mg Eluxadoline<br>* Oral Tablets<br>|
| Experimental: Double Blind 6-11 years of age: Eluxadoline 50mg<br>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 | Drug: 25mg Eluxadoline<br>* Oral Tablets<br>|
| Experimental: Double Blind 12-17 years of age: Eluxadoline 25mg<br>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 | Drug: 25mg Eluxadoline<br>* Oral Tablets<br>|
| Experimental: Double Blind 12-17 years of age: Eluxadoline 50mg<br>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 | Drug: 25mg Eluxadoline<br>* Oral Tablets<br>|
| Experimental: Double Blind 12-17 years of age: Eluxadoline 100mg<br>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 | Drug: 25mg Eluxadoline<br>* Oral Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome with Diarrhea IBSD IBS-D Irritable Bowel Syndrome Pediatric