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NCT03339128PHASE2Recruiting

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

AbbVie

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

Inclusion Criteria: * Participant must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures. * Participant is a male or female outpatient, 6 to 17 years of age inclusive, at the time the participant provides assent for the study and parent/guardian/LAR has provided signed consent. * Participant is able to read and understand the assessments in the eDiary. If the participant is 6 to 11 years of age and does not meet this criterion, the interviewer-administered version of the eDiary must be used and the parent/guardian/LAR or caregiver who will be administering the interviewer-administered version of the eDiary must be able to read and understand the assessments in the eDiary and must undergo training. * Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. Female participants of childbearing potential must have a negative serum pregnancy test at Visit 1 (screening) and a negative urine pregnancy test at Visit 3 (randomization) prior to dosing. * Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug. Local practices may require 2 methods of birth control. Female participants of non-childbearing potential do not need to use birth control. * Participant has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria: Must include all of the following: \-- Abdominal pain at least 4 days per month over at least 2 months associated with one or more of the following: * Related to defecation * A change in frequency of stool * A change in form (appearance) of stool * After appropriate evaluation, the symptoms cannot be fully explained by another medical condition. * Participant has predominantly diarrheal stool symptoms defined as Bristol stool types 6 or 7 for more than 25% of bowel movements and Bristol stool types 1 or 2 for less than 25% of bowel movements that occur in the absence of laxative. * Participant may be newly diagnosed with IBS-D by the investigator at Visit 1. All criteria for diagnosis must be fulfilled for at least 2 months prior to Visit 1 (screening). * Participant has been compliant with the eDiary by completing both the morning and evening assessments for at least 8 out of the 14 days immediately preceding Visit 3 (randomization). * Participant has an average daytime abdominal pain score greater than or equal to 1.0 over the 2 weeks prior to randomization. * Participant has at least 1 daytime bowel movement with a consistency of Type 6 or Type 7 on the pediatric Bristol Stool Form Scale (p-BSFS) on at least 2 days per week during the 2 weeks immediately prior to randomization and that occurs in the absence of laxatives. Exclusion Criteria: * Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy). * Participant has had any of the following surgeries: * Any abdominal surgery within the 3 months prior to Screening; or * A history of major gastric, hepatic, pancreatic, or intestinal surgery. (Note: appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed. For the purposes of this study, laparoscopic surgeries without complication are considered minor and non-exclusionary, provided the condition for which the surgery was performed was not exclusionary.) * Participant has a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction. * Participant has a history or current diagnosis of constipation with encopresis. * Participant meets the child/adolescent Rome IV criteria of IBS with constipation, IBS with constipation and diarrhea (mixed), unspecified IBS, or functional constipation. * Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation. * Participant has a documented history of hepatic impairment as defined by Child-Pugh Classification Grade A, B or C. * Participant has a history or current diagnosis of inflammatory or immune-mediated lower GI disorders including inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, microscopic colitis). Crohn's disease affecting the upper GI tract would also be exclusionary. * Participant has celiac disease, or a positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy. * Participant has any congenital and/or acquired malabsorption syndrome (eg, Shwachman-Diamond syndrome). * Participant has a history of a microbiologically documented (ie, stool culture or medical history) GI infection within 3 months prior to Screening. * Participant has a known lactose or fructose intolerance that is associated with diarrhea, abdominal pain or discomfort, and that could confound assessments in the study. * Participant has a history of diverticulitis within 3 months prior to Screening.

Interventions

DRUG

Eluxadoline

DRUG

Placebo

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Conditions

Irritable Bowel Syndrome

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