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

Recruiting now · Phase 3

Conditions studied: Bowel Cleansing Prior to Clinical Procedures

In brief

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.

Key facts

Study ID

NCT07218523

Run by

Norgine

People needed

212

Starts

2025-12-29

Expected to finish

2027-01-06

Last updated by the study team

2026-05-27

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz — Miskolc, Miskolc, Hungary (enrolling)
• Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel) — Jette, Brussels Capital, Belgium (enrolling)
• Clinique CHC MontLegia — Alleur, Liege, Belgium (enrolling)
• Krankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin — Regensburg, Bavaria, Germany (enrolling)
• Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Allgemeine Paediatrie — Münster, North Rhine-Westphalia, Germany (enrolling)
• Helios Uniklinikum Wuppertal — Wuppertal, North Rhine-Westphalia, Germany (enrolling)
• Universitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR — Mainz, Rhineland-Palatinate, Germany (enrolling)
• Charité Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (enrolling)
• Semmelweis Egyetem Gyermekgyogyaszati Klinika Bokay Utcai Reszleg — Budapest, Budapest, Hungary (enrolling)
• Heim Pal Orszagos Gyermekgyogyaszati Intezet — Budapest, Budapest, Hungary (enrolling)
• Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Antwerp, Belgium (enrolling)
• NHS Lothian - Royal Hospital for Children & Young People — Edinburgh, Edinburgh, City of, United Kingdom (enrolling)
• Great North Children's Hospital - Royal Victoria Infirmary — Newcastle upon Tyne, Newcastle Upon Tyne, United Kingdom (enrolling)
• Sheffield Children's NHS Foundation Trust - Sheffield Children's Hospital — Sheffield, Sheffield, United Kingdom (enrolling)
• King's College Hospital NHS Foundation Trust — London, York, United Kingdom (enrolling)
• Birmingham Women's and Children's NHS Foundation Trust - Birmingham Children's Hospital — Birmingham, United Kingdom (enrolling)
• Barts Health NHS Trust — London, United Kingdom (enrolling)
• Azienda Ospedaliera Universitaria Meyer IRCCS — Florence, Firenze, Italy (enrolling)
• Azienda Ospedaliera Universitaria Gaetano Martino — Messina, Messina, Italy (enrolling)
• Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda — Milan, Milano, Italy (enrolling)
• Azienda Ospedaliera Universitaria Federico II - Pediatria Generale — Naples, Napoli, Italy (enrolling)
• Azienda Ospealiero Universitaria Policlinico Umberto I — Roma, Roma, Italy (enrolling)
• Policlinico Gemelli - Endoscopia Digestiva Chirurgica — Roma, Roma, Italy (enrolling)
• Amphia Hospital - Pediatrics — Breda, North Brabant, Netherlands (enrolling)
• Amsterdam UMC - Pediatrics — Amsterdam, North Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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