Clinical trial

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

Name

3030-302-002

Description

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.

Trial arms

Trial start

2021-08-13

Estimated PCD

2027-03-15

Trial end

2027-03-15

Phase

Early phase I

Treatment

25mg Eluxadoline

Oral Tablets

Arms:

Double Blind 12-17 years of age: Eluxadoline 100mg, Double Blind 12-17 years of age: Eluxadoline 25mg, Double Blind 12-17 years of age: Eluxadoline 50mg, Double Blind 6-11 years of age: Eluxadoline 25mg, Double Blind 6-11 years of age: Eluxadoline 50mg, Open Label 12-17 years of age: Eluxadoline 100 mg, Open Label 6-11 years of age: Eluxadoline 50mg

100mg Eluxadoline

Oral Tablets

Arms:

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

Size

124

Primary endpoint

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 124, 'type': 'ESTIMATED'}}

Updated at

2023-05-24

1 organization

1 product

1 indication

Product

Eluxadoline

Indication

Irritable Bowel Syndrome

Organization

Allergan