Eluxadoline for Pediatric IBS-D
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: AbbVie
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial will check the safety of a medication called Eluxadoline for children with IBS-D who have already taken part in earlier studies. The medication helps to reduce diarrhea and stomach pain by slowing down bowel movements. Eluxadoline is a new drug approved for managing diarrhea predominant irritable bowel syndrome (IBS-D).
Eligibility Criteria
This trial is for kids aged 6-17 with IBS-D who've finished a previous Phase 2 or Phase 3 study. They can't join if they're pregnant, nursing, plan to be pregnant, have opioid allergies, no gallbladder, biliary or pancreatic issues, severe liver/kidney/blood conditions, alcohol abuse history or intend to drink during the study.Inclusion Criteria
Participants must have completed study intervention in their lead-in study
I am between 6 and 17 years old.
Exclusion Criteria
I have had pancreatitis or problems with my pancreas structure.
I have a blockage in my bile ducts or issues with the sphincter of Oddi.
You have an ongoing health issue or abnormal results from medical tests that may affect your safety or ability to participate in the study.
+6 more
Participant Groups
The trial tests long-term safety of Eluxadoline (100mg and 25mg doses) in children with IBS-D. It's for those who completed earlier phases of the research and now need further evaluation over an extended period.
7Treatment groups
Experimental Treatment
Group I: Open Label 6-11 years of age: Eluxadoline 50mgExperimental Treatment1 Intervention
Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day.
Group II: Open Label 12-17 years of age: Eluxadoline 100 mgExperimental Treatment2 Interventions
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 III: Double Blind 6-11 years of age: Eluxadoline 50mgExperimental Treatment1 Intervention
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 IV: Double Blind 6-11 years of age: Eluxadoline 25mgExperimental Treatment1 Intervention
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 V: Double Blind 12-17 years of age: Eluxadoline 50mgExperimental Treatment1 Intervention
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 VI: Double Blind 12-17 years of age: Eluxadoline 25mgExperimental Treatment1 Intervention
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 VII: Double Blind 12-17 years of age: Eluxadoline 100mgExperimental Treatment1 Intervention
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
Eluxadoline is already approved in United States for the following indications:
🇺🇸 Approved in United States as Viberzi for:
- Irritable Bowel Syndrome with Diarrhea (IBS-D)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
IPS Research CompanyOklahoma City, OK
Preferred Primary Care Physicians, Inc. /ID# 227596Pittsburgh, PA
Kindred Medical Institute, LLC /ID# 227595Corona, CA
Valencia Medical & Research Center /ID# 246221Miami, FL
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
AllerganLead Sponsor