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

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат Eluxadoline
  Oral tablets
• Препарат Placebo
  Oral tablets

Первичные конечные точки

• Change from baseline in stool consistency averaged over the 4-week Treatment Period [Срок оценки: Baseline (2 Weeks prior to randomization) to Week 4]

Вторичные конечные точки (5)

• Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores [Срок оценки: Baseline (2 Weeks prior to randomization) to Week 4]
• Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores [Срок оценки: Baseline (2 Weeks prior to randomization) to Week 4]
• Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency [Срок оценки: Baseline (2 Weeks prior to randomization) to Week 4]
• Change from baseline for daytime, nighttime, and 24 hour urgency-free days [Срок оценки: Baseline (2 Weeks prior to randomization) to Week 4]
• Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days [Срок оценки: Baseline (2 Weeks prior to randomization) to Week 4]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 26 центров

• HealthStar Research of Hot Springs PLLC /ID# 234609 — Hot Springs
• Applied Research Center of Arkansas /ID# 238070 — Little Rock
• Kindred Medical Institute, LLC /ID# 237368 — Corona
• Duplicate_VVCRD Research /ID# 234606 — Garden Grove
• Duplicate_Center for Clinical Trials LLC /ID# 234630 — Paramount
• Sunrise Research Institute /ID# 237382 — Miami
• South Miami Medical & Research Group Inc. /ID# 234655 — Miami
• Valencia Medical & Research Center /ID# 234672 — Miami
• … и ещё 18 центров

Польша · 6 центров

• Specjalistyczne Gabinety Sp. z o.o. /ID# 236347 — Krakow
• Centrum Zdrowia MDM /ID# 237269 — Warsaw
• Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311 — Warsaw
• Korczowski Bartosz Gabinet Lekarski /ID# 234683 — Rzeszów
• Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656 — Gdansk
• Instytut Centrum Zdrowia Matki Polki /ID# 237438 — Lodz

Болгария · 3 центра

• Medical center 1 Sevlievo /ID# 237473 — Sevlievo
• MHATSv.Ivan Rilski /ID# 235399 — Kozloduy
• University Hospital Plovdiv /ID# 235450 — Plovdiv

Венгрия · 3 центра

• Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993 — Budapest
• Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341 — Sopron
• Vita Verum Medical Bt. /ID# 234321 — Székesfehérvár

Великобритания · 3 центра

• Kings College Hospital NHS Foundation Trust /ID# 236305 — London
• Duplicate_Manchester University NHS Foundation Trust /ID# 234663 — Manchester
• Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273 — Blackpool

Канада · 2 центра

• Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917 — Edmonton
• Manitoba Institute of Child Health /ID# 235448 — Winnepeg

Германия · 1 центр

• HELIOS Klinikum Wuppertal /ID# 237322 — Wuppertal

Нидерланды · 1 центр

• Duplicate_Academisch Medisch Centrum /ID# 237117 — Amsterdam

Испания · 1 центр

• Hospital Universitario Dr. Peset /ID# 236755 — Valencia

Идентификаторы

NCT: NCT03339128 · 3030-202-002 · 2017-003770-14

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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