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)

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Eluxadoline

• Study Type: Interventional
• Enrollment (Estimated): 95
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Bulgaria
  • Kozloduy, Bulgaria, 3320
    • Completed
    • MHATSv.Ivan Rilski /ID# 235399
  • Plovdiv, Bulgaria, 4001
    • Completed
    • University Hospital Plovdiv /ID# 235450
  • Gabrovo
    • Sevlievo, Gabrovo, Bulgaria, 5400
      • Completed
      • Medical center 1 Sevlievo /ID# 237473
• Canada
  • Edmonton, Canada, T6G 1C9
    • Completed
    • Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917
  • Winnepeg, Canada, R3E 3P4
    • Completed
    • Manitoba Institute of Child Health /ID# 235448
• Germany
  • Wuppertal, Germany, 42283
    • Completed
    • HELIOS Klinikum Wuppertal /ID# 237322
• Hungary
  • Budapest, Hungary, 1125
    • Completed
    • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
  • Sopron, Hungary, 9400
    • Completed
    • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
  • Székesfehérvár, Hungary, 8000
    • Completed
    • Vita Verum Medical Bt. /ID# 234321
• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1105 AZ
      • Completed
      • Duplicate_Academisch Medisch Centrum /ID# 237117
• Poland
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-539
      • Completed
      • Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-189
      • Completed
      • Centrum Zdrowia MDM /ID# 237269
    • Warsaw, Masovian Voivodeship, Poland, 04-730
      • Completed
      • Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-302
      • Completed
      • Korczowski Bartosz Gabinet Lekarski /ID# 234683
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-803
      • Completed
      • Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 93-338
      • Completed
      • Instytut Centrum Zdrowia Matki Polki /ID# 237438
• Spain
  • Valencia, Spain, 46017
    • Completed
    • Hospital Universitario Dr. Peset /ID# 236755
• United Kingdom
  • Blackpool, United Kingdom, FY3 8NR
    • Completed
    • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
  • Greater London
    • London, Greater London, United Kingdom, SE5 9RS
      • Completed
      • Kings College Hospital NHS Foundation Trust /ID# 236305
  • Lancashire
    • Manchester, Lancashire, United Kingdom, M13 9WL
      • Completed
      • Duplicate_Manchester University NHS Foundation Trust /ID# 234663
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Recruiting
      • HealthStar Research of Hot Springs PLLC /ID# 234609
    • Little Rock, Arkansas, United States, 72212-4187
      • Recruiting
      • Applied Research Center of Arkansas /ID# 238070
  • California
    • Corona, California, United States, 92879
      • Completed
      • Kindred Medical Institute, LLC /ID# 237368
    • Garden Grove, California, United States, 92845
      • Completed
      • Duplicate_VVCRD Research /ID# 234606
    • Paramount, California, United States, 90723
      • Completed
      • Duplicate_Center for Clinical Trials LLC /ID# 234630
  • Florida
    • Miami, Florida, United States, 33130
      • Completed
      • Sunrise Research Institute /ID# 237382
    • Miami, Florida, United States, 33155
      • Recruiting
      • South Miami Medical & Research Group Inc. /ID# 234655
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Miami, Florida, United States, 33165
      • Recruiting
      • Valencia Medical & Research Center /ID# 234672
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Miami, Florida, United States, 33174
      • Recruiting
      • Florida Research Center, Inc. /ID# 236514
    • Miami Lakes, Florida, United States, 33016
      • Completed
      • Duplicate_Wellness Clinical Research /ID# 237401
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Completed
      • Children's Ctr Digestive, US /ID# 237575
    • Atlanta, Georgia, United States, 30315
      • Recruiting
      • Global Research Associates /ID# 234646
    • Stockbridge, Georgia, United States, 30281
      • Recruiting
      • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Completed
      • Advocate Children's Hospital-Park Ridge /ID# 235388
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Completed
      • Indiana University Health Riley Hospital for Children /ID# 235400
  • Kentucky
    • Lexington, Kentucky, United States, 40517
      • Completed
      • Michael W. Simon, MD, PSC /ID# 236517
  • Maryland
    • New Market, Maryland, United States, 21774-6154
      • Completed
      • Frederick County Pediatrics /ID# 234519
  • Minnesota
    • Minneapolis, Minnesota, United States, 55413-2195
      • Completed
      • MNGI Digestive Health, P. A. /ID# 238057
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Completed
      • Celen Medical Group Corp /ID# 234922
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • Completed
      • IPS Research Company /ID# 237672
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4319
      • Completed
      • Children's Hospital of Philadelphia - Main /ID# 234313
    • Pittsburgh, Pennsylvania, United States, 15236
      • Recruiting
      • Preferred Primary Care Physicians, Inc. /ID# 236436
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Completed
      • Cook Children's Med. Center /ID# 237537
    • Houston, Texas, United States, 77030-2608
      • Recruiting
      • Texas Children's Hospital /ID# 238304
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • San Antonio, Texas, United States, 78215
      • Completed
      • Sun Research Institute /ID# 236933
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University Hospitals /ID# 256841

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eluxadoline 25mg; Eluxadoline 25mg, oral administration, twice daily	Drug: Eluxadoline; Oral tablets; Other Names: Viberzi
Experimental: Eluxadoline 50mg; Eluxadoline 50mg, oral administration, twice daily	Drug: Eluxadoline; Oral tablets; Other Names: Viberzi
Experimental: Eluxadoline 100mg; Eluxadoline 100mg, oral administration, twice daily	Drug: Eluxadoline; Oral tablets; Other Names: Viberzi
Experimental: Placebo; Dose-matched placebo, oral administration, twice daily	Drug: Placebo; Oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores	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
Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores	Abdominal Pain is scored on a five-point ordinal scale, with 0 meaning no pain, and 4 meaning a lot of pain.	Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency	Change from baseline in the number of bowel movements.	Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days	Change from baseline in the number of fecal incontinence-free days in a week.	Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24 hour urgency-free days	Change from baseline in the number of urgency free days in a week.	Baseline (2 Weeks prior to randomization) to Week 4

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; IBS; Pediatric; IBS-D; Irritable Bowel Syndrome with Diarrhea; IBSD
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Substandard Drugs; Pharmaceutical Preparations; eluxadoline
• Other Study ID Numbers: 3030-202-002; 2017-003770-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No