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

NCT03339128 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 3030-202-0022017-003770-14
• Study Type: interventional
• Target: 95
• Locations: 9 countries
• Sites: 46

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome with Diarrhea; IBS; IBSD; IBS-D; Irritable Bowel Syndrome; Pediatric

Outcome Measures

Primary Outcomes (1)

• Change from baseline in stool consistency averaged over the 4-week Treatment Period

  Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).

  Baseline (2 Weeks prior to randomization) to Week 4

Secondary Outcomes (5)

• Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores

  Baseline (2 Weeks prior to randomization) to Week 4

• Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores

  Baseline (2 Weeks prior to randomization) to Week 4

• Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency

  Baseline (2 Weeks prior to randomization) to Week 4

• Change from baseline for daytime, nighttime, and 24 hour urgency-free days

  Baseline (2 Weeks prior to randomization) to Week 4

• Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days

  Baseline (2 Weeks prior to randomization) to Week 4

Study Arms (4)

Eluxadoline 25mg

EXPERIMENTAL

Eluxadoline 25mg, oral administration, twice daily

Drug: Eluxadoline

Eluxadoline 50mg

EXPERIMENTAL

Eluxadoline 50mg, oral administration, twice daily

Drug: Eluxadoline

Eluxadoline 100mg

EXPERIMENTAL

Eluxadoline 100mg, oral administration, twice daily

Drug: Eluxadoline

Placebo

EXPERIMENTAL

Dose-matched placebo, oral administration, twice daily

Drug: Placebo

Interventions

Eluxadoline DRUG

Oral tablets

Also known as: Viberzi

Eluxadoline 100mg; Eluxadoline 25mg; Eluxadoline 50mg

Placebo DRUG

Oral tablets

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (46)

HealthStar Research of Hot Springs PLLC /ID# 234609

Hot Springs, Arkansas, 71913, United States

RECRUITING

Applied Research Center of Arkansas /ID# 238070

Little Rock, Arkansas, 72212-4187, United States

RECRUITING

Kindred Medical Institute, LLC /ID# 237368

Corona, California, 92879, United States

COMPLETED

Duplicate_VVCRD Research /ID# 234606

Garden Grove, California, 92845, United States

COMPLETED

Duplicate_Center for Clinical Trials LLC /ID# 234630

Paramount, California, 90723, United States

COMPLETED

Sunrise Research Institute /ID# 237382

Miami, Florida, 33130, United States

COMPLETED

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

Miami, Florida, 33155, United States

RECRUITING

Valencia Medical & Research Center /ID# 234672

Miami, Florida, 33165, United States

RECRUITING

Florida Research Center, Inc. /ID# 236514

Miami, Florida, 33174, United States

RECRUITING

Duplicate_Wellness Clinical Research /ID# 237401

Miami Lakes, Florida, 33016, United States

COMPLETED

Global Research Associates /ID# 234646

Atlanta, Georgia, 30315, United States

RECRUITING

Children's Ctr Digestive, US /ID# 237575

Atlanta, Georgia, 30342, United States

COMPLETED

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

Stockbridge, Georgia, 30281, United States

RECRUITING

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

Park Ridge, Illinois, 60068, United States

COMPLETED

Indiana University Health Riley Hospital for Children /ID# 235400

Indianapolis, Indiana, 46202, United States

COMPLETED

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

Lexington, Kentucky, 40517, United States

COMPLETED

Frederick County Pediatrics /ID# 234519

New Market, Maryland, 21774-6154, United States

COMPLETED

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

Minneapolis, Minnesota, 55413-2195, United States

COMPLETED

Celen Medical Group Corp /ID# 234922

Marlton, New Jersey, 08053, United States

COMPLETED

IPS Research Company /ID# 237672

Oklahoma City, Oklahoma, 73106, United States

COMPLETED

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

Philadelphia, Pennsylvania, 19104-4319, United States

COMPLETED

Preferred Primary Care Physicians, Inc. /ID# 236436

Pittsburgh, Pennsylvania, 15236, United States

RECRUITING

Cook Children's Med. Center /ID# 237537

Fort Worth, Texas, 76104, United States

COMPLETED

Texas Children's Hospital /ID# 238304

Houston, Texas, 77030-2608, United States

RECRUITING

Sun Research Institute /ID# 236933

San Antonio, Texas, 78215, United States

COMPLETED

West Virginia University Hospitals /ID# 256841

Morgantown, West Virginia, 26506, United States

RECRUITING

Medical center 1 Sevlievo /ID# 237473

Sevlievo, Gabrovo, 5400, Bulgaria

COMPLETED

MHATSv.Ivan Rilski /ID# 235399

Kozloduy, 3320, Bulgaria

COMPLETED

University Hospital Plovdiv /ID# 235450

Plovdiv, 4001, Bulgaria

COMPLETED

Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917

Edmonton, T6G 1C9, Canada

COMPLETED

Manitoba Institute of Child Health /ID# 235448

Winnepeg, R3E 3P4, Canada

COMPLETED

HELIOS Klinikum Wuppertal /ID# 237322

Wuppertal, 42283, Germany

COMPLETED

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

Budapest, 1125, Hungary

COMPLETED

Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341

Sopron, 9400, Hungary

COMPLETED

Vita Verum Medical Bt. /ID# 234321

Székesfehérvár, 8000, Hungary

COMPLETED

Duplicate_Academisch Medisch Centrum /ID# 237117

Amsterdam, North Holland, 1105 AZ, Netherlands

COMPLETED

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

Krakow, Lesser Poland Voivodeship, 30-539, Poland

COMPLETED

Centrum Zdrowia MDM /ID# 237269

Warsaw, Masovian Voivodeship, 00-189, Poland

COMPLETED

Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311

Warsaw, Masovian Voivodeship, 04-730, Poland

COMPLETED

Korczowski Bartosz Gabinet Lekarski /ID# 234683

Rzeszów, Podkarpackie Voivodeship, 35-302, Poland

COMPLETED

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

Gdansk, Pomeranian Voivodeship, 80-803, Poland

COMPLETED

Instytut Centrum Zdrowia Matki Polki /ID# 237438

Lodz, Łódź Voivodeship, 93-338, Poland

COMPLETED

Hospital Universitario Dr. Peset /ID# 236755

Valencia, 46017, Spain

COMPLETED

Kings College Hospital NHS Foundation Trust /ID# 236305

London, Greater London, SE5 9RS, United Kingdom

COMPLETED

Duplicate_Manchester University NHS Foundation Trust /ID# 234663

Manchester, Lancashire, M13 9WL, United Kingdom

COMPLETED

Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273

Blackpool, FY3 8NR, United Kingdom

COMPLETED

Related Links

• Related Info

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

eluxadoline

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: November 15, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

ES (1); HU (3); GB (3); CA (2); NL (1); PL (6); DE (1); US (26); BU (3)