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Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT03339128•AbbVie

View on ClinicalTrials.gov

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

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

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.
+5 more criteria

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

Key Dates

Start Date

November 15, 2017

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

September 19, 2025

Enrollment

ESTIMATED participants

Conditions

Irritable Bowel Syndrome

Interventions

Eluxadoline

DRUG

Placebo

DRUG

Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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