Clinical trial NCT03339128: Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome with Diarrhea
IBS
IBSD
IBS-D
Irritable Bowel Syndrome
Pediatric
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-11-13
Enrollment: 95
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Change from baseline in stool consistency averaged over the 4-week Treatment Period
timeFrame: Baseline (2 Weeks prior to randomization) to Week 4
Secondary outcomes:
measure: Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores
timeFrame: Baseline (2 Weeks prior to randomization) to Week 4
measure: Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores
timeFrame: Baseline (2 Weeks prior to randomization) to Week 4
measure: Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency
timeFrame: Baseline (2 Weeks prior to randomization) to Week 4
measure: Change from baseline for daytime, nighttime, and 24 hour urgency-free days
timeFrame: Baseline (2 Weeks prior to randomization) to Week 4
measure: Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days
timeFrame: Baseline (2 Weeks prior to randomization) to Week 4
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: HealthStar Research of Hot Springs PLLC /ID# 234609
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas /ID# 238070
state: Arkansas
city: Corona
country: United States
facility: Kindred Medical Institute, LLC /ID# 237368
state: California
city: Garden Grove
country: United States
facility: Duplicate_VVCRD Research /ID# 234606
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials LLC /ID# 234630
state: California
city: Miami Lakes
country: United States
facility: Duplicate_Wellness Clinical Research /ID# 237401
state: Florida
city: Miami
country: United States
facility: Sunrise Research Institute /ID# 237382
state: Florida
city: Miami
country: United States
facility: South Miami Medical & Research Group Inc. /ID# 234655
state: Florida
city: Miami
country: United States
facility: Valencia Medical & Research Center /ID# 234672
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc. /ID# 236514
state: Florida
city: Atlanta
country: United States
facility: Global Research Associates /ID# 234646
state: Georgia
city: Atlanta
country: United States
facility: Children's Ctr Digestive, US /ID# 237575
state: Georgia
city: Stockbridge
country: United States
facility: Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343
state: Georgia
city: Park Ridge
country: United States
facility: Advocate Children's Hospital-Park Ridge /ID# 235388
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Riley Hospital for Children /ID# 235400
state: Indiana
city: Lexington
country: United States
facility: Michael W. Simon, MD, PSC /ID# 236517
state: Kentucky
city: New Market
country: United States
facility: Frederick County Pediatrics /ID# 234519
state: Maryland
city: Minneapolis
country: United States
facility: MNGI Digestive Health, P. A. /ID# 238057
state: Minnesota
city: Marlton
country: United States
facility: Celen Medical Group Corp /ID# 234922
state: New Jersey
city: Oklahoma City
country: United States
facility: IPS Research Company /ID# 237672
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia - Main /ID# 234313
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc. /ID# 236436
state: Pennsylvania
city: Fort Worth
country: United States
facility: Cook Children's Med. Center /ID# 237537
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital /ID# 238304
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute /ID# 236933
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Hospitals /ID# 256841
state: West Virginia
city: Sevlievo
country: Bulgaria
facility: Medical center 1 Sevlievo /ID# 237473
state: Gabrovo
city: Kozloduy
country: Bulgaria
facility: MHATSv.Ivan Rilski /ID# 235399
city: Plovdiv
country: Bulgaria
facility: University Hospital Plovdiv /ID# 235450
city: Edmonton
country: Canada
facility: Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917
city: Winnepeg
country: Canada
facility: Manitoba Institute of Child Health /ID# 235448
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal /ID# 237322
city: Budapest
country: Hungary
facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
city: Sopron
country: Hungary
facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
city: Szekesfehervar
country: Hungary
facility: Vita Verum Medical Bt. /ID# 234321
city: Amsterdam
country: Netherlands
facility: Duplicate_Academisch Medisch Centrum /ID# 237117
state: Noord-Holland
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki /ID# 237438
state: Lodzkie
city: Krakow
country: Poland
facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
state: Malopolskie
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM /ID# 237269
state: Mazowieckie
city: Warszawa
country: Poland
facility: Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Korczowski Bartosz Gabinet Lekarski /ID# 234683
state: Podkarpackie
city: Gdansk
country: Poland
facility: Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
state: Pomorskie
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset /ID# 236755
city: Manchester
country: United Kingdom
facility: Duplicate_Manchester University NHS Foundation Trust /ID# 234663
state: Lancashire
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust /ID# 236305
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: