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

Part of paid clinical trials in Corona, California.

Sponsor
AbbVie
Study ID
NCT04880876
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Irritable Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 25mg Eluxadoline — DRUG
    Oral Tablets
  • 100mg Eluxadoline — DRUG
    Oral Tablets

Study Details

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.

Key Dates

Start date
Aug 13, 2021
Status verified
Jul 2025
Primary completion
Dec 31, 2032
Completion
Dec 31, 2032

Study Design

Enrollment
124 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Percentage of Participants with Adverse Events [ Time Frame: 52 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
Kindred Medical Institute, LLC /ID# 227595CoronaCalifornia92879-
Florida Research Center, Inc. /ID# 227597MiamiFlorida33174-
Valencia Medical & Research Center /ID# 246221MiamiFlorida33165-
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600StockbridgeGeorgia30281-
IPS Research Company /ID# 227594Oklahoma CityOklahoma73106-
Preferred Primary Care Physicians, Inc. /ID# 227596PittsburghPennsylvania15236-

Find similar trials in Corona, CA

By research site
Kindred Medical Institute, LLC· Corona, CAFlorida Research Center, Inc.· Miami, FLValencia Medical & Research Center· Miami, FLSleep Care Research Institute d/b/a Clinical Research Institute· Stockbridge, GAIPS Research Company· Oklahoma City, OKPreferred Primary Care Physicians, Inc.· Pittsburgh, PA

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