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

Irritable Bowel Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03339128
• Other study ID #: 3030-202-002
• Secondary ID: 2017-003770-14
• Status: Recruiting
• Phase: Phase 2
• Start date: November 15, 2017
• Est. completion date: December 15, 2026

Study information

• Verified date: December 2023
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: December 15, 2026
• Est. primary completion date: December 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Eluxadoline
Oral tablets
• Placebo
Oral tablets

Locations

Country	Name	City	State
Bulgaria	MHATSv.Ivan Rilski /ID# 235399	Kozloduy
Bulgaria	University Hospital Plovdiv /ID# 235450	Plovdiv
Bulgaria	Medical center 1 Sevlievo /ID# 237473	Sevlievo
Canada	Edmonton Clinic Health Academy (ECHA) /ID# 234917	Edmonton
Hungary	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	Szekesfehervar
Netherlands	Academisch Medisch Centrum /ID# 237117	Amsterdam
Poland	Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656	Gdansk
Poland	Specjalistyczne Gabinety Sp. z o.o. /ID# 236347	Krakow	Malopolskie
Poland	Instytut Centrum Zdrowia Matki Polki /ID# 237438	Lodz	Lodzkie
Poland	Korczowski Bartosz Gabinet Lekarski /ID# 234683	Rzeszow
Poland	Centrum Zdrowia MDM /ID# 237269	Warszawa	Mazowieckie
Poland	Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311	Warszawa	Mazowieckie
United Kingdom	Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273	Blackpool
United Kingdom	King's College Hospital NHS Foundation Trust /ID# 236305	London
United Kingdom	Manchester University NHS Foundation Trust /ID# 234663	Manchester	Lancashire
United States	Children's Ctr Digestive, US /ID# 237575	Atlanta	Georgia
United States	Global Research Associates /ID# 234646	Atlanta	Georgia
United States	Kindred Medical Institute, LLC /ID# 237368	Corona	California
United States	Cook Children's Med. Center /ID# 237537	Fort Worth	Texas
United States	VVCRD Research /ID# 234606	Garden Grove	California
United States	HealthStar Research of Hot Springs PLLC /ID# 234609	Hot Springs	Arkansas
United States	Texas Children's Hospital /ID# 238304	Houston	Texas
United States	Riley Hospital for Children at Indiana University Health /ID# 235400	Indianapolis	Indiana
United States	Michael W. Simon, MD, PSC /ID# 236517	Lexington	Kentucky
United States	Applied Research Center of Arkansas /ID# 238070	Little Rock	Arkansas
United States	Celen Medical Group Corp /ID# 234922	Marlton	New Jersey
United States	Florida Research Center, Inc. /ID# 236514	Miami	Florida
United States	South Miami Medical & Research Group Inc. /ID# 234655	Miami	Florida
United States	Sunrise Research Institute /ID# 237382	Miami	Florida
United States	Valencia Medical & Research Center /ID# 234672	Miami	Florida
United States	Wellness Clinical Research /ID# 237401	Miami Lakes	Florida
United States	MNGI Digestive Health, P. A. /ID# 238057	Minneapolis	Minnesota
United States	IPS Research Company /ID# 237672	Oklahoma City	Oklahoma
United States	Center for Clinical Trials LLC /ID# 234630	Paramount	California
United States	Advocate Children's Hospital-Park Ridge /ID# 235388	Park Ridge	Illinois
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	Sun Research Institute /ID# 236933	San Antonio	Texas
United States	Virgo Carter Pediatrics /ID# 234519	Silver Spring	Maryland
United States	Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343	Stockbridge	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Hungary,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in stool consistency averaged over the 4-week Treatment Period	Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).	Baseline (2 Weeks prior to randomization) to Week 4
Secondary	Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores	Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).	Baseline (2 Weeks prior to randomization) to Week 4
Secondary	Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores	Abdominal Pain is scored on a five-point ordinal scale, with 0 meaning no pain, and 4 meaning a lot of pain.	Baseline (2 Weeks prior to randomization) to Week 4
Secondary	Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency	Change from baseline in the number of bowel movements.	Baseline (2 Weeks prior to randomization) to Week 4
Secondary	Change from baseline for daytime, nighttime, and 24 hour urgency-free days	Change from baseline in the number of urgency free days in a week.	Baseline (2 Weeks prior to randomization) to Week 4
Secondary	Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days	Change from baseline in the number of fecal incontinence-free days in a week.	Baseline (2 Weeks prior to randomization) to Week 4

External Links

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