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Clinical Trials in Germany / NCT07218523
Recruiting Phase 3

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

NCT07218523 · tracked via the Priya Life Science Germany tracker
Sponsor
Norgine
Phase
Phase 3
Started
2025-12-29
Last updated
2026-05-27

Condition(s) studied

Bowel Cleansing Prior to Clinical Procedures

Investigational drug(s) / intervention(s)

PLENVU® →Sodium picosulfate →

PLENVU®: PLENVU® will be administered as an oral solution.

Sodium picosulfate: Sodium picosulfate will be administered as an oral solution.

Study summary

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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Universitair Ziekenhuis Antwerpen (UZA) Edegem Antwerp Recruiting
Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel) Jette Brussels Capital Recruiting
Clinique CHC MontLegia Alleur Liege Recruiting
Krankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin Regensburg Bavaria Recruiting
Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Allgemeine Paediatrie Münster North Rhine-Westphalia Recruiting
Helios Uniklinikum Wuppertal Wuppertal North Rhine-Westphalia Recruiting
Universitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR Mainz Rhineland-Palatinate Recruiting
Charité Universitätsmedizin Berlin Berlin State of Berlin Recruiting
Semmelweis Egyetem Gyermekgyogyaszati Klinika Bokay Utcai Reszleg Budapest Budapest Recruiting
Heim Pal Orszagos Gyermekgyogyaszati Intezet Budapest Budapest Recruiting
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz Miskolc Miskolc Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo Bergamo Not Yet Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Firenze Recruiting
Azienda Ospedaliera Universitaria Gaetano Martino Messina Messina Recruiting
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda Milan Milano Recruiting
Azienda Ospedaliera di Rilievo Nazionale (AORN) Santobono Pausilipon Naples Napoli Not Yet Recruiting
Azienda Ospedaliera Universitaria Federico II - Pediatria Generale Naples Napoli Recruiting
AOU Università degli studi della Campania Luigi Vanvitelli, Policlinico di Napoli - Pediatria Naples Napoli Not Yet Recruiting
Azienda Ospealiero Universitaria Policlinico Umberto I Roma Roma Recruiting
Policlinico Gemelli - Endoscopia Digestiva Chirurgica Roma Roma Recruiting
Azienda Ospedaliero-Universitaria Sant'Andrea - Pediatria Roma Roma Withdrawn
Amphia Hospital - Pediatrics Breda North Brabant Recruiting
Amsterdam UMC - Pediatrics Amsterdam North Holland Recruiting
Isala Klinieken Zwolle Overijssel Recruiting
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu - Oddzial Pediatrii i Gastroenterologii Torun Kuyavian-Pomeranian Voivodeship Recruiting
Uniwersytecki Szpital Dzieciecy w Krakowie Krakow Lesser Poland Voivodeship Not Yet Recruiting
Instytut "Pomnik - Centrum Zdrowia Dziecka" - Oddzial Gastroenterologii, Hepatologii, Zaburzen Odzywiania i Pediatrii Warsaw Masovian Voivodeship Recruiting
Uniwersytecki Dzieciecy Szpital Kliniczny Imienia Ludwika Zamenhofa w Bialymstoku - Klinika Pediatrii, Gastroenterologii, Hepato Bialystok Podlaskie Voivodeship Not Yet Recruiting
Gdanski Uniwersytet Medyczny (GUMed) - Katedra i Klinika Pediatrii, Gastroenterologii, Alergologii i Zywienia Dzieci Gdansk Pomeranian Voivodeship Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanislawa Szyszko SUM w Katowicach Oddzial Gastroenterologii i Hepatolog Zabrze Silesian Voivodeship Recruiting
Complejo Hospitalario Universitario de Ferrol Ferrol A Coruña Recruiting
Hospital Universitario Son Espases Palma de Mallorca Balearic Islands Recruiting
Parc Tauli Hospital Universitarli Sabadell Barcelona Recruiting
Hospital Infantil Universitario Niño Jesús Madrid Madrid Recruiting
Hospital Materno Infantil de Málaga Málaga Málaga Recruiting
NHS Lothian - Royal Hospital for Children & Young People Edinburgh Edinburgh, City of Recruiting
Great North Children's Hospital - Royal Victoria Infirmary Newcastle upon Tyne Newcastle Upon Tyne Recruiting
Sheffield Children's NHS Foundation Trust - Sheffield Children's Hospital Sheffield Sheffield Recruiting
King's College Hospital NHS Foundation Trust London York Recruiting
Birmingham Women's and Children's NHS Foundation Trust - Birmingham Children's Hospital Birmingham United Kingdom Recruiting

+ 1 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07218523 on ClinicalTrials.gov ↗ ← All trials in Germany