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)

Who is this study for? Patients with Irritable Bowel Syndrome
What treatments are being studied? Eluxadoline
Status: Recruiting
Location: See all (46) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
HealthStar Research of Hot Springs PLLC /ID# 234609
RECRUITING
Hot Springs
Applied Research Center of Arkansas /ID# 238070
RECRUITING
Little Rock
California
Kindred Medical Institute, LLC /ID# 237368
COMPLETED
Corona
Duplicate_VVCRD Research /ID# 234606
COMPLETED
Garden Grove
Duplicate_Center for Clinical Trials LLC /ID# 234630
COMPLETED
Paramount
Florida
Florida Research Center, Inc. /ID# 236514
RECRUITING
Miami
South Miami Medical & Research Group Inc. /ID# 234655
RECRUITING
Miami
Sunrise Research Institute /ID# 237382
COMPLETED
Miami
Valencia Medical & Research Center /ID# 234672
RECRUITING
Miami
Duplicate_Wellness Clinical Research /ID# 237401
COMPLETED
Miami Lakes
Georgia
Children's Ctr Digestive, US /ID# 237575
COMPLETED
Atlanta
Global Research Associates /ID# 234646
RECRUITING
Atlanta
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343
RECRUITING
Stockbridge
Illinois
Advocate Children's Hospital-Park Ridge /ID# 235388
COMPLETED
Park Ridge
Indiana
Indiana University Health Riley Hospital for Children /ID# 235400
COMPLETED
Indianapolis
Kentucky
Michael W. Simon, MD, PSC /ID# 236517
COMPLETED
Lexington
Maryland
Frederick County Pediatrics /ID# 234519
COMPLETED
New Market
Minnesota
MNGI Digestive Health, P. A. /ID# 238057
COMPLETED
Minneapolis
New Jersey
Celen Medical Group Corp /ID# 234922
COMPLETED
Marlton
Oklahoma
IPS Research Company /ID# 237672
COMPLETED
Oklahoma City
Pennsylvania
Children's Hospital of Philadelphia - Main /ID# 234313
COMPLETED
Philadelphia
Preferred Primary Care Physicians, Inc. /ID# 236436
RECRUITING
Pittsburgh
Texas
Cook Children's Med. Center /ID# 237537
COMPLETED
Fort Worth
Texas Children's Hospital /ID# 238304
RECRUITING
Houston
Sun Research Institute /ID# 236933
COMPLETED
San Antonio
West Virginia
West Virginia University Hospitals /ID# 256841
RECRUITING
Morgantown
Other Locations
Bulgaria
MHATSv.Ivan Rilski /ID# 235399
COMPLETED
Kozloduy
University Hospital Plovdiv /ID# 235450
COMPLETED
Plovdiv
Medical center 1 Sevlievo /ID# 237473
COMPLETED
Sevlievo
Canada
Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917
COMPLETED
Edmonton
Manitoba Institute of Child Health /ID# 235448
COMPLETED
Winnepeg
Germany
HELIOS Klinikum Wuppertal /ID# 237322
COMPLETED
Wuppertal
Hungary
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
COMPLETED
Budapest
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
COMPLETED
Sopron
Vita Verum Medical Bt. /ID# 234321
COMPLETED
Székesfehérvár
Netherlands
Duplicate_Academisch Medisch Centrum /ID# 237117
COMPLETED
Amsterdam
Poland
Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
COMPLETED
Gdansk
Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
COMPLETED
Krakow
Instytut Centrum Zdrowia Matki Polki /ID# 237438
COMPLETED
Lodz
Korczowski Bartosz Gabinet Lekarski /ID# 234683
COMPLETED
Rzeszów
Centrum Zdrowia MDM /ID# 237269
COMPLETED
Warsaw
Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
COMPLETED
Warsaw
Spain
Hospital Universitario Dr. Peset /ID# 236755
COMPLETED
Valencia
United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
COMPLETED
Blackpool
Kings College Hospital NHS Foundation Trust /ID# 236305
COMPLETED
London
Duplicate_Manchester University NHS Foundation Trust /ID# 234663
COMPLETED
Manchester
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2017-11-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 95
Treatments
Experimental: Eluxadoline 25mg
Eluxadoline 25mg, oral administration, twice daily
Experimental: Eluxadoline 50mg
Eluxadoline 50mg, oral administration, twice daily
Experimental: Eluxadoline 100mg
Eluxadoline 100mg, oral administration, twice daily
Experimental: Placebo
Dose-matched placebo, oral administration, twice daily
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov