RECRUITING

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

Conditions

Irritable Bowel Syndrome Irritable Bowel Syndrome with Diarrhea IBS IBSD IBS-D Pediatric

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2017-11-15

Study Completion:2026-12-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03339128

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.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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: * 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.	* 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.

Inclusion Criteria

Exclusion 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:
* 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.

* 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.

Contacts and Locations

Study Contact

ABBVIE CALL CENTER

CONTACT

844-663-3742

abbvieclinicaltrials@abbvie.com

Principal Investigator

ABBVIE INC.

STUDY_DIRECTOR

AbbVie

Study Locations (Sites)

HealthStar Research of Hot Springs PLLC /ID# 234609

Hot Springs, Arkansas, 71913

United States

Applied Research Center of Arkansas /ID# 238070

Little Rock, Arkansas, 72212-4187

United States

Kindred Medical Institute, LLC /ID# 237368

Corona, California, 92879

United States

VVCRD Research /ID# 234606

Garden Grove, California, 92845

United States

Center for Clinical Trials LLC /ID# 234630

Paramount, California, 90723

United States

Duplicate_Wellness Clinical Research /ID# 237401

Miami Lakes, Florida, 33016

United States

Sunrise Research Institute /ID# 237382

Miami, Florida, 33130

United States

South Miami Medical & Research Group Inc. /ID# 234655

Miami, Florida, 33155

United States

Valencia Medical & Research Center /ID# 234672

Miami, Florida, 33165

United States

Florida Research Center, Inc. /ID# 236514

Miami, Florida, 33174

United States

Global Research Associates /ID# 234646

Atlanta, Georgia, 30315

United States

Children's Ctr Digestive, US /ID# 237575

Atlanta, Georgia, 30342

United States

Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343

Stockbridge, Georgia, 30281

United States

Advocate Children's Hospital-Park Ridge /ID# 235388

Park Ridge, Illinois, 60068

United States

Indiana University Health Riley Hospital for Children /ID# 235400

Indianapolis, Indiana, 46202

United States

Michael W. Simon, MD, PSC /ID# 236517

Lexington, Kentucky, 40517

United States

Virgo Carter Pediatrics /ID# 234519

Silver Spring, Maryland, 20910

United States

MNGI Digestive Health, P. A. /ID# 238057

Minneapolis, Minnesota, 55413-2195

United States

Celen Medical Group Corp /ID# 234922

Marlton, New Jersey, 08053

United States

IPS Research Company /ID# 237672

Oklahoma City, Oklahoma, 73106

United States

Children's Hospital of Philadelphia - Main /ID# 234313

Philadelphia, Pennsylvania, 19104-4319

United States

Preferred Primary Care Physicians, Inc. /ID# 236436

Pittsburgh, Pennsylvania, 15236

United States

Cook Children's Med. Center /ID# 237537

Fort Worth, Texas, 76104

United States

Texas Children's Hospital /ID# 238304

Houston, Texas, 77030-2608

United States

Sun Research Institute /ID# 236933

San Antonio, Texas, 78215

United States

Collaborators and Investigators

Sponsor: AbbVie

ABBVIE INC., STUDY_DIRECTOR, AbbVie

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 Registration Dates

Study Start Date2017-11-15

Study Completion Date2026-12-14

Study Record Updates

Study Start Date2017-11-15

Study Completion Date2026-12-14

Terms related to this study

Keywords Provided by Researchers

Irritable Bowel Syndrome with Diarrhea
IBS
IBSD
IBS-D
Irritable Bowel Syndrome
Pediatric

Additional Relevant MeSH Terms

Irritable Bowel Syndrome