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

September 17, 2025 updated by: AbbVie

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in stool consistency averaged over the 4-week Treatment Period
Time Frame: Baseline (2 Weeks prior to randomization) to Week 4
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores
Time Frame: Baseline (2 Weeks prior to randomization) to Week 4
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
Time Frame: Baseline (2 Weeks prior to randomization) to Week 4
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
Time Frame: Baseline (2 Weeks prior to randomization) to Week 4
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
Time Frame: Baseline (2 Weeks prior to randomization) to Week 4
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
Time Frame: Baseline (2 Weeks prior to randomization) to Week 4
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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