Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
AbbVie
Study ID
NCT03339128
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Irritable Bowel Syndrome

Eligibility Criteria

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

Interventions

  • Eluxadoline — DRUG
    Oral tablets
  • Placebo — DRUG
    Oral tablets

Study Details

The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue.

Key Dates

Start date
Nov 15, 2017
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
95 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Eluxadoline 25mg
    Eluxadoline 25mg, oral administration, twice daily
  • Experimental: Eluxadoline 50mg
    Eluxadoline 50mg, oral administration, twice daily
  • Experimental: Eluxadoline 100mg
    Eluxadoline 100mg, oral administration, twice daily
  • Experimental: Placebo
    Dose-matched placebo, oral administration, twice daily

Primary Outcome Measure

Change from baseline in stool consistency averaged over the 4-week Treatment Period [ Time Frame: Baseline (2 Weeks prior to randomization) to Week 4 ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
HealthStar Research of Hot Springs PLLC /ID# 234609Hot SpringsArkansas71913-
Applied Research Center of Arkansas /ID# 238070Little RockArkansas72212-4187-
Kindred Medical Institute, LLC /ID# 237368CoronaCalifornia92879-
Duplicate_VVCRD Research /ID# 234606Garden GroveCalifornia92845-
Duplicate_Center for Clinical Trials LLC /ID# 234630ParamountCalifornia90723-
Florida Research Center, Inc. /ID# 236514MiamiFlorida33174-
South Miami Medical & Research Group Inc. /ID# 234655MiamiFlorida33155
Site Coordinator
844-663-3742
Sunrise Research Institute /ID# 237382MiamiFlorida33130-
Valencia Medical & Research Center /ID# 234672MiamiFlorida33165-
Duplicate_Wellness Clinical Research /ID# 237401Miami LakesFlorida33016-
Children's Ctr Digestive, US /ID# 237575AtlantaGeorgia30342-
Global Research Associates /ID# 234646AtlantaGeorgia30315-
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343StockbridgeGeorgia30281-
Advocate Children's Hospital-Park Ridge /ID# 235388Park RidgeIllinois60068-
Indiana University Health Riley Hospital for Children /ID# 235400IndianapolisIndiana46202-
Michael W. Simon, MD, PSC /ID# 236517LexingtonKentucky40517-
Frederick County Pediatrics /ID# 234519New MarketMaryland21774-6154-
MNGI Digestive Health, P. A. /ID# 238057MinneapolisMinnesota55413-2195-
Celen Medical Group Corp /ID# 234922MarltonNew Jersey08053-
IPS Research Company /ID# 237672Oklahoma CityOklahoma73106-
Children's Hospital of Philadelphia - Main /ID# 234313PhiladelphiaPennsylvania19104-4319-
Preferred Primary Care Physicians, Inc. /ID# 236436PittsburghPennsylvania15236-
Cook Children's Med. Center /ID# 237537Fort WorthTexas76104-
Texas Children's Hospital /ID# 238304HoustonTexas77030-2608
Site Coordinator
844-663-3742
Sun Research Institute /ID# 236933San AntonioTexas78215-
West Virginia University Hospitals /ID# 256841MorgantownWest Virginia26506-

Find similar trials in Hot Springs, AR

By research site
HealthStar Research of Hot Springs PLLC· Hot Springs, ARApplied Research Center of Arkansas· Little Rock, ARKindred Medical Institute, LLC· Corona, CADuplicate_VVCRD Research· Garden Grove, CADuplicate_Center for Clinical Trials LLC· Paramount, CAFlorida Research Center, Inc.· Miami, FL

Related Studies