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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
212
PLENVU® will be administered as an oral solution.
Sodium picosulfate will be administered as an oral solution.
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerp, Belgium
NOT_YET_RECRUITINGUniversitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
Jette, Brussels Capital, Belgium
NOT_YET_RECRUITINGClinique CHC MontLegia
Alleur, Liege, Belgium
NOT_YET_RECRUITINGKrankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin
Regensburg, Bavaria, Germany
Percentage of participants achieving adequate bowel cleansing based on Boston Bowel Preparation Scale (BBPS)
To describe the success rate of bowel cleansing in paediatric participants after administration of PLENVU® or sodium picosulfate as measured by the BBPS. The BBPS is a scoring system used to assess bowel cleanliness during colonoscopy. The scale ranges from 0 to 3, evaluating the three colonic segments (i.e. right colon, transverse colon, and left colon) where a score of 0 indicates an unprepared colon segment with mucosa not visible due to solid stool, and 3 indicates mucosa of colon segment seen well, with bowel cleansing success defined as a score of ≥2 in all three segments.
Time frame: Day 2
Percentage of participants achieving successful bowel cleansing based on Harefield Cleansing Scale (HCS)
To describe the success rate of bowel cleansing in paediatric participants after administration of PLENVU® or sodium picosulfate as measured by the HCS. The HCS is scoring system used to assess bowel cleanliness during colonoscopy. The scale ranges from 0 to 4 evaluating five segments (i.e. ascending colon, transverse colon, descending colon, sigmoid colon and rectum). The scores of the five segments will be the basis for a final grading of A, B, C, or D. Success is defined as a HCS grade of A or B.
Time frame: Day 2
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)
To determine the safety of PLENVU® as compared to sodium picosulfate in paediatric participants.
Time frame: 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
To determine the tolerability, palatability and acceptability of PLENVU® as compared to sodium picosulfate. A paediatric 5-point Likert Scale will be used to assess the tolerability, palatability and acceptability. It uses a combination of facial expressions and simple language to make it easier for children to understand and respond.
Time frame: Day 1 and Day 2
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Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Allgemeine Paediatrie
Münster, North Rhine-Westphalia, Germany
NOT_YET_RECRUITINGHelios Uniklinikum Wuppertal
Wuppertal, North Rhine-Westphalia, Germany
NOT_YET_RECRUITINGUniversitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR
Mainz, Rhineland-Palatinate, Germany
NOT_YET_RECRUITINGCharité Universitätsmedizin Berlin
Berlin, Germany
NOT_YET_RECRUITINGSemmelweis Egyetem Gyermekgyogyaszati Klinika Bokay Utcai Reszleg
Budapest, Hungary
NOT_YET_RECRUITINGHeim Pal Orszagos Gyermekgyogyaszati Intezet
Budapest, Hungary
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