A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy

Официальное название

A Phase 3, Multicentre, Randomised (1:1), Parallel-group, Active-controlled, Central Reader Colonoscopist-blind Study to Evaluate the Bowel Cleansing Efficacy, Safety, Tolerability, Palatability, and Acceptability of PLENVU® as Compared to Sodium Picosulfate in Paediatric Participants From 1 to < 18 Years of Age in Preparation for Colonoscopy (CLARITY)

Обзор

The purpose of the study is to assess the efficacy, safety and tolerability of PLENVU® by measuring its bowel cleansing success rate compared to sodium picosulfate in paediatric participants aged less than 18 years who are scheduled to undergo a colonoscopy. Colonoscopy is a crucial procedure that helps to diagnose and manage various gastrointestinal (GI) conditions in paediatric patients. An adequate level of bowel preparation and cleansing is essential for effective colonoscopy to allow proper visualisation of the bowel.

Подробное описание

This is a multicentre, active-controlled study in which the participants will be randomised 1:1 into one of two treatment groups - PLENVU® or sodium picosulfate in a 2-day split dosing regimen. The study will include -

1. A Screening Period of up to 28 days (Day -28 to Day -1). 2. A Treatment Period (Day 1 to Day 2) - Participants will be randomised to receive either PLENVU® or sodium picosulfate. Participants will be admitted into the Clinical Research Unit (CRU) on Day 1 and will remain in the CRU for the duration of study intervention administration (Day 1 and Day 2) and colonoscopy (Day 2). Participants will be discharged on Day 2 following the colonoscopy and evaluation of colon cleansing. 3. A safety follow-up call or CRU visit (Day 9 ± 2 days).

Вмешательства

• Препарат PLENVU®
  PLENVU® will be administered as an oral solution.
• Препарат Sodium picosulfate
  Sodium picosulfate will be administered as an oral solution.

Первичные конечные точки

• Percentage of participants achieving adequate bowel cleansing based on Boston Bowel Preparation Scale (BBPS) [Срок оценки: Day 2]

Вторичные конечные точки (3)

• Percentage of participants achieving successful bowel cleansing based on Harefield Cleansing Scale (HCS) [Срок оценки: Day 2]
• Number of participants with Adverse events (AEs) and Serious adverse events (SAEs) [Срок оценки: From Screening (Day -28 to Day -1) to safety follow-up (Day 9 ± 2 days)]
• Number of participants with a response on the Likert Scale [Срок оценки: Day 1 and Day 2]

Критерии участия

Критерии включения

• Participants who require a colonoscopy.
• Must weigh a minimum of 10 kg, and participants aged 1 to < 4 years of age must be above the 10th percentile of weight for age.
• Must have a negative urine pregnancy test (or serum if a urine pregnancy test cannot be confirmed as negative \[e.g. three ambiguous results\]) within 24 hours before the first dose of study intervention.
• Must use a highly effective method of contraception (failure rate < 1% per year) from Day 1 and throughout the Safety Follow-up Period.
• Must not be breastfeeding.
• Participant is able to receive regular external feeding without breastfeeding.

Критерии исключения

• Has a past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution).
• Has known or suspected ileus, GI obstruction, gastric retention, bowel perforation, toxic colitis, ischaemic colitis, or megacolon.
• Has ongoing severe acute inflammatory bowel disease that contraindicates colonoscopy.
• Participant has history of significant GI surgeries.
• Has known glucose-6-phosphate dehydrogenase (G6PD) deficiency or phenylketonuria.
• Participant has a past history within the last 12 months or evidence of any ongoing clinically relevant electrocardiogram (ECG) abnormalities (e.g. arrhythmias).
• Has a history of uncontrolled hypertension.
• Participant has regularly used laxatives or colon motility altering drugs in the last month (i.e. more than two times per week) and/or has used one or more laxatives within 72 hours prior to administration of the preparation.
• Has known hypersensitivity or allergic reaction to PEG, ascorbic acid, sodium picosulfate, magnesium oxide, or any other component of the investigational product or comparator.
• Received or scheduled to receive any vaccines or devices within one week prior to first dose of study intervention.
• Has a significant neurological disorder or a past history of seizures (excluding simple febrile seizures) or is currently on medication lowering seizure threshold (e.g. tricyclic antidepressants) or has used seizure threshold lowering medication within 14 days prior to administration of the preparation.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 10 центров

• Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII — Bergamo
• Azienda Ospedaliera Universitaria Meyer IRCCS — Florence
• Azienda Ospedaliera Universitaria Gaetano Martino — Messina
• Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda — Milan
• Azienda Ospedaliera di Rilievo Nazionale (AORN) Santobono Pausilipon — Naples
• Azienda Ospedaliera Universitaria Federico II - Pediatria Generale — Naples
• AOU Università degli studi della Campania Luigi Vanvitelli, Policlinico di Napoli - Pediat — Naples
• Azienda Ospealiero Universitaria Policlinico Umberto I — Roma
• … и ещё 2 центра

Польша · 6 центров

• Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu - Oddzial Pediatrii i Gastroentero — Torun
• Uniwersytecki Szpital Dzieciecy w Krakowie — Krakow
• Instytut "Pomnik - Centrum Zdrowia Dziecka" - Oddzial Gastroenterologii, Hepatologii, Zabu — Warsaw
• Uniwersytecki Dzieciecy Szpital Kliniczny Imienia Ludwika Zamenhofa w Bialymstoku - Klinik — Bialystok
• Gdanski Uniwersytet Medyczny (GUMed) - Katedra i Klinika Pediatrii, Gastroenterologii, Ale — Gdansk
• Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanislawa Szyszko SUM w Katowicach — Zabrze

Великобритания · 6 центров

• NHS Lothian - Royal Hospital for Children & Young People — Edinburgh
• Great North Children's Hospital - Royal Victoria Infirmary — Newcastle upon Tyne
• Sheffield Children's NHS Foundation Trust - Sheffield Children's Hospital — Sheffield
• King's College Hospital NHS Foundation Trust — London
• Birmingham Women's and Children's NHS Foundation Trust - Birmingham Children's Hospital — Birmingham
• Barts Health NHS Trust — London

Германия · 5 центров

• Krankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin — Regensburg
• Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Allgemeine — Münster
• Helios Uniklinikum Wuppertal — Wuppertal
• Universitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR — Mainz
• Charité Universitätsmedizin Berlin — Berlin

Испания · 5 центров

• Complejo Hospitalario Universitario de Ferrol — Ferrol
• Hospital Universitario Son Espases — Palma de Mallorca
• Parc Tauli Hospital Universitarli — Sabadell
• Hospital Infantil Universitario Niño Jesús — Madrid
• Hospital Materno Infantil de Málaga — Málaga

Бельгия · 3 центра

• Universitair Ziekenhuis Antwerpen (UZA) — Edegem
• Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Bru — Jette
• Clinique CHC MontLegia — Alleur

Венгрия · 3 центра

• Semmelweis Egyetem Gyermekgyogyaszati Klinika Bokay Utcai Reszleg — Budapest
• Heim Pal Orszagos Gyermekgyogyaszati Intezet — Budapest
• Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz — Miskolc

Нидерланды · 3 центра

• Amphia Hospital - Pediatrics — Breda
• Amsterdam UMC - Pediatrics — Amsterdam
• Isala Klinieken — Zwolle

Идентификаторы

NCT: NCT07218523 · NER1006-01/2025 · 2025-522046-42-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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