RecruitingPhase 2NCT03339128

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Pediatric Participants (Age 6 to 17 Years) With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Sponsor

AbbVie

Enrollment

95 participants

Start Date

Nov 15, 2017

Study Type

INTERVENTIONAL

Conditions

Irritable Bowel Syndrome

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

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Eluxadoline and a drug called Placebo for people with irritable bowel syndrome. The study is currently recruiting participants at 46 locations. People eligible for this study include aged 6 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEluxadoline

Oral tablets

DRUGPlacebo

Oral tablets

Locations(46)

HealthStar Research of Hot Springs PLLC /ID# 234609

Hot Springs, Arkansas, United States

Applied Research Center of Arkansas /ID# 238070

Little Rock, Arkansas, United States

Kindred Medical Institute, LLC /ID# 237368

Corona, California, United States

Duplicate_VVCRD Research /ID# 234606

Garden Grove, California, United States

Duplicate_Center for Clinical Trials LLC /ID# 234630

Paramount, California, United States

Sunrise Research Institute /ID# 237382

Miami, Florida, United States

South Miami Medical & Research Group Inc. /ID# 234655

Miami, Florida, United States

Valencia Medical & Research Center /ID# 234672

Miami, Florida, United States

Florida Research Center, Inc. /ID# 236514

Miami, Florida, United States

Duplicate_Wellness Clinical Research /ID# 237401

Miami Lakes, Florida, United States

Global Research Associates /ID# 234646

Atlanta, Georgia, United States

Children's Ctr Digestive, US /ID# 237575

Atlanta, Georgia, United States

Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343

Stockbridge, Georgia, United States

Advocate Children's Hospital-Park Ridge /ID# 235388

Park Ridge, Illinois, United States

Indiana University Health Riley Hospital for Children /ID# 235400

Indianapolis, Indiana, United States

Michael W. Simon, MD, PSC /ID# 236517

Lexington, Kentucky, United States

Frederick County Pediatrics /ID# 234519

New Market, Maryland, United States

MNGI Digestive Health, P. A. /ID# 238057

Minneapolis, Minnesota, United States

Celen Medical Group Corp /ID# 234922

Marlton, New Jersey, United States

IPS Research Company /ID# 237672

Oklahoma City, Oklahoma, United States

Children's Hospital of Philadelphia - Main /ID# 234313

Philadelphia, Pennsylvania, United States

Preferred Primary Care Physicians, Inc. /ID# 236436

Pittsburgh, Pennsylvania, United States

Cook Children's Med. Center /ID# 237537

Fort Worth, Texas, United States

Texas Children's Hospital /ID# 238304

Houston, Texas, United States

Sun Research Institute /ID# 236933

San Antonio, Texas, United States

West Virginia University Hospitals /ID# 256841

Morgantown, West Virginia, United States

Medical center 1 Sevlievo /ID# 237473

Sevlievo, Gabrovo, Bulgaria

MHATSv.Ivan Rilski /ID# 235399

Kozloduy, Bulgaria

University Hospital Plovdiv /ID# 235450

Plovdiv, Bulgaria

Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917

Edmonton, Canada

Manitoba Institute of Child Health /ID# 235448

Winnepeg, Canada

HELIOS Klinikum Wuppertal /ID# 237322

Wuppertal, Germany

Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993

Budapest, Hungary

Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341

Sopron, Hungary

Vita Verum Medical Bt. /ID# 234321

Székesfehérvár, Hungary

Duplicate_Academisch Medisch Centrum /ID# 237117

Amsterdam, North Holland, Netherlands

Specjalistyczne Gabinety Sp. z o.o. /ID# 236347

Krakow, Lesser Poland Voivodeship, Poland

Centrum Zdrowia MDM /ID# 237269

Warsaw, Masovian Voivodeship, Poland

Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311

Warsaw, Masovian Voivodeship, Poland

Korczowski Bartosz Gabinet Lekarski /ID# 234683

Rzeszów, Podkarpackie Voivodeship, Poland

Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656

Gdansk, Pomeranian Voivodeship, Poland

Instytut Centrum Zdrowia Matki Polki /ID# 237438

Lodz, Łódź Voivodeship, Poland

Hospital Universitario Dr. Peset /ID# 236755

Valencia, Spain

Kings College Hospital NHS Foundation Trust /ID# 236305

London, Greater London, United Kingdom

Duplicate_Manchester University NHS Foundation Trust /ID# 234663

Manchester, Lancashire, United Kingdom

Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273

Blackpool, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03339128

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