Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
Start Date
11/15/2017
Completion Date
12/1/2026
Summary
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.
Eligibility Criteria
Age Range: 6 years to 17 years
Interventions
Eluxadoline
Placebo
Conditions
Locations
HealthStar Research of Hot Springs PLLC /ID# 234609
Hot Springs, Arkansas 71913
United States
Applied Research Center of Arkansas /ID# 238070
Little Rock, Arkansas 72212-4187
United States
Kindred Medical Institute, LLC /ID# 237368
Corona, California 92879
United States
Duplicate_VVCRD Research /ID# 234606
Garden Grove, California 92845
United States
Duplicate_Center for Clinical Trials LLC /ID# 234630
Paramount, California 90723
United States
Sunrise Research Institute /ID# 237382
Miami, Florida 33130
United States
South Miami Medical & Research Group Inc. /ID# 234655
Miami, Florida 33155
United States
Valencia Medical & Research Center /ID# 234672
Miami, Florida 33165
United States
Florida Research Center, Inc. /ID# 236514
Miami, Florida 33174
United States
Duplicate_Wellness Clinical Research /ID# 237401
Miami Lakes, Florida 33016
United States
Global Research Associates /ID# 234646
Atlanta, Georgia 30315
United States
Children's Ctr Digestive, US /ID# 237575
Atlanta, Georgia 30342
United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343
Stockbridge, Georgia 30281
United States
Advocate Children's Hospital-Park Ridge /ID# 235388
Park Ridge, Illinois 60068
United States
Indiana University Health Riley Hospital for Children /ID# 235400
Indianapolis, Indiana 46202
United States
Michael W. Simon, MD, PSC /ID# 236517
Lexington, Kentucky 40517
United States
Frederick County Pediatrics /ID# 234519
New Market, Maryland 21774-6154
United States
MNGI Digestive Health, P. A. /ID# 238057
Minneapolis, Minnesota 55413-2195
United States
Celen Medical Group Corp /ID# 234922
Marlton, New Jersey 08053
United States
IPS Research Company /ID# 237672
Oklahoma City, Oklahoma 73106
United States
Children's Hospital of Philadelphia - Main /ID# 234313
Philadelphia, Pennsylvania 19104-4319
United States
Preferred Primary Care Physicians, Inc. /ID# 236436
Pittsburgh, Pennsylvania 15236
United States
Cook Children's Med. Center /ID# 237537
Fort Worth, Texas 76104
United States
Texas Children's Hospital /ID# 238304
Houston, Texas 77030-2608
United States
Sun Research Institute /ID# 236933
San Antonio, Texas 78215
United States
West Virginia University Hospitals /ID# 256841
Morgantown, West Virginia 26506
United States
Medical center 1 Sevlievo /ID# 237473
Sevlievo, Gabrovo 5400
Bulgaria
MHATSv.Ivan Rilski /ID# 235399
Kozloduy, 3320
Bulgaria
University Hospital Plovdiv /ID# 235450
Plovdiv, 4001
Bulgaria
Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917
Edmonton, T6G 1C9
Canada
Manitoba Institute of Child Health /ID# 235448
Winnepeg, R3E 3P4
Canada
HELIOS Klinikum Wuppertal /ID# 237322
Wuppertal, 42283
Germany
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
Budapest, 1125
Hungary
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
Sopron, 9400
Hungary
Vita Verum Medical Bt. /ID# 234321
Székesfehérvár, 8000
Hungary
Duplicate_Academisch Medisch Centrum /ID# 237117
Amsterdam, North Holland 1105 AZ
Netherlands
Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
Krakow, Lesser Poland Voivodeship 30-539
Poland
Centrum Zdrowia MDM /ID# 237269
Warsaw, Masovian Voivodeship 00-189
Poland
Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
Warsaw, Masovian Voivodeship 04-730
Poland
Korczowski Bartosz Gabinet Lekarski /ID# 234683
Rzeszów, Podkarpackie Voivodeship 35-302
Poland
Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
Gdansk, Pomeranian Voivodeship 80-803
Poland
Instytut Centrum Zdrowia Matki Polki /ID# 237438
Lodz, Łódź Voivodeship 93-338
Poland
Hospital Universitario Dr. Peset /ID# 236755
Valencia, 46017
Spain
Kings College Hospital NHS Foundation Trust /ID# 236305
London, Greater London SE5 9RS
United Kingdom
Duplicate_Manchester University NHS Foundation Trust /ID# 234663
Manchester, Lancashire M13 9WL
United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
Blackpool, FY3 8NR
United Kingdom