Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
NCT ID: NCT03339128
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
95 participants
INTERVENTIONAL
2017-11-15
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Eluxadoline 25mg
Eluxadoline 25mg, oral administration, twice daily
Eluxadoline
Oral tablets
Eluxadoline 50mg
Eluxadoline 50mg, oral administration, twice daily
Eluxadoline
Oral tablets
Eluxadoline 100mg
Eluxadoline 100mg, oral administration, twice daily
Eluxadoline
Oral tablets
Placebo
Dose-matched placebo, oral administration, twice daily
Placebo
Oral tablets
Interventions
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Eluxadoline
Oral tablets
Placebo
Oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Years
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Global Research Associates /ID# 234646
Atlanta, Georgia, United States
Children's Ctr Digestive, US /ID# 237575
Atlanta, Georgia, United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343
Stockbridge, Georgia, United States
Advocate Children's Hospital-Park Ridge /ID# 235388
Park Ridge, Illinois, United States
Indiana University Health Riley Hospital for Children /ID# 235400
Indianapolis, Indiana, United States
Michael W. Simon, MD, PSC /ID# 236517
Lexington, Kentucky, United States
Frederick County Pediatrics /ID# 234519
New Market, Maryland, United States
MNGI Digestive Health, P. A. /ID# 238057
Minneapolis, Minnesota, United States
Celen Medical Group Corp /ID# 234922
Marlton, New Jersey, United States
IPS Research Company /ID# 237672
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia - Main /ID# 234313
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians, Inc. /ID# 236436
Pittsburgh, Pennsylvania, United States
Cook Children's Med. Center /ID# 237537
Fort Worth, Texas, United States
Texas Children's Hospital /ID# 238304
Houston, Texas, United States
Sun Research Institute /ID# 236933
San Antonio, Texas, United States
West Virginia University Hospitals /ID# 256841
Morgantown, West Virginia, United States
Medical center 1 Sevlievo /ID# 237473
Sevlievo, Gabrovo, Bulgaria
MHATSv.Ivan Rilski /ID# 235399
Kozloduy, , Bulgaria
University Hospital Plovdiv /ID# 235450
Plovdiv, , Bulgaria
Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917
Edmonton, , Canada
Manitoba Institute of Child Health /ID# 235448
Winnepeg, , Canada
HELIOS Klinikum Wuppertal /ID# 237322
Wuppertal, , Germany
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
Budapest, , Hungary
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
Sopron, , Hungary
Vita Verum Medical Bt. /ID# 234321
Székesfehérvár, , Hungary
Duplicate_Academisch Medisch Centrum /ID# 237117
Amsterdam, North Holland, Netherlands
Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
Krakow, Lesser Poland Voivodeship, Poland
Centrum Zdrowia MDM /ID# 237269
Warsaw, Masovian Voivodeship, Poland
Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
Warsaw, Masovian Voivodeship, Poland
Korczowski Bartosz Gabinet Lekarski /ID# 234683
Rzeszów, Podkarpackie Voivodeship, Poland
Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
Gdansk, Pomeranian Voivodeship, Poland
Instytut Centrum Zdrowia Matki Polki /ID# 237438
Lodz, Łódź Voivodeship, Poland
Hospital Universitario Dr. Peset /ID# 236755
Valencia, , Spain
Kings College Hospital NHS Foundation Trust /ID# 236305
London, Greater London, United Kingdom
Duplicate_Manchester University NHS Foundation Trust /ID# 234663
Manchester, Lancashire, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
Blackpool, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2017-003770-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3030-202-002
Identifier Type: -
Identifier Source: org_study_id
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