A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
- Registration Number
- NCT04880876
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 124
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double Blind 6-11 years of age: Eluxadoline 50mg 25mg Eluxadoline 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 Double Blind 12-17 years of age: Eluxadoline 100mg 25mg Eluxadoline 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 Double Blind 12-17 years of age: Eluxadoline 25mg 25mg Eluxadoline 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 Double Blind 12-17 years of age: Eluxadoline 50mg 25mg Eluxadoline 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 Open Label 6-11 years of age: Eluxadoline 50mg 25mg Eluxadoline Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day. Open Label 12-17 years of age: Eluxadoline 100 mg 25mg Eluxadoline 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. Open Label 12-17 years of age: Eluxadoline 100 mg 100mg Eluxadoline 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. Double Blind 6-11 years of age: Eluxadoline 25mg 25mg Eluxadoline 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
- Primary Outcome Measures
Name Time Method 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 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Florida Research Center, Inc. /ID# 227597
🇺🇸Miami, Florida, United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600
🇺🇸Stockbridge, Georgia, United States
Preferred Primary Care Physicians, Inc. /ID# 227596
🇺🇸Pittsburgh, Pennsylvania, United States
IPS Research Company /ID# 227594
🇺🇸Oklahoma City, Oklahoma, United States