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Study finishedPhase2

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

Sponsor: AbbVie

NCT ID: NCT03339128

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Eluxadoline (drug), Placebo (drug)
How long the study runs
Study runs about 105 months (dates as stated)
About the drug or intervention
Eluxadoline — drug: Oral tablets · Placebo — drug: Oral tablets
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
6 Years to 17 Years
Who
All
Number of participants
272
Started
2017-11-15
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for irritable bowel syndrome
  • • Phase2 - 272 participants
  • • 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

Who can take part?

  • • Ages 6 Years to 17 Years
  • • Diagnosed with irritable bowel syndrome

Where?

  • • London - Kings College Hospital NHS Foundation Trust /ID# 236305
  • • Manchester - Duplicate_Manchester University NHS Foundation Trust /ID# 234663
  • • Blackpool - Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Irritable Bowel Syndrome

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 6 Years - 17 Years
  • Who can join: All genders

Biomarkers mentioned

have a negativeand a negativeor a positive

Treatment history

Treatments you must have had:

  • ✓ 2 methods of birth control

What the study is looking for

  • ✓Participant must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed...
  • ✓Participant is a male or female outpatient, 6 to 17 years of age inclusive, at the time the participant provides...
  • ✓Participant has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria: Must include all...
  • ✓\-- Abdominal pain at least 4 days per month over at least 2 months associated with one or more of the following:
  • ✓Related to defecation

Who cannot take part

  • ✗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...
  • ✗Participant has a history or current diagnosis of constipation with encopresis.
See the full criteria
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.

Where Is This Study? (3 UK sites)

Kings College Hospital NHS Foundation Trust /ID# 236305

London SE5 9RS, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Duplicate_Manchester University NHS Foundation Trust /ID# 234663

Manchester M13 9WL, United Kingdom

Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273

Blackpool FY3 8NR, United Kingdom

Hospital R&D contact (matched)

Dr Angela Parker

bfwh.randd.office@nhs.net01253 (9) 51514 / (9) 55547
Data sourced from ClinicalTrials.gov · Last verified: 2026-09