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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Percentage of participants achieving adequate bowel cleansing based on Boston Bowel Preparation Scale (BBPS) — Day 2
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.
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| Clinical Hospital Centre Rijeka | Rijeka | Primorje-Gorski Kotar County | 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| Helios Uniklinikum Wuppertal | Wuppertal | North Rhine-Westphalia | Withdrawn |
| Universitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR | Mainz | Rhineland-Palatinate | Withdrawn |
| 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 | 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 | 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 | 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 | 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 | Recruiting |
| Gdanski Uniwersytet Medyczny (GUMed) - Katedra i Klinika Pediatrii, Gastroenterologii, Alergologii i Zywienia Dzieci | Gdansk | Pomeranian Voivodeship | Withdrawn |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanislawa Szyszko SUM w Katowicach Oddzial Gastroenterologii i Hepatolog | Zabrze | Silesian Voivodeship | Recruiting |
| Centro Clínico Académico(CCA) - Braga, Associação (2CA-Braga) | Braga | Braga District | Recruiting |
| Hospital Pediatrico da Unidad Local de Saude de Coimbra | Coimbra | Coimbra District | Not Yet Recruiting |
| Hospital da Luz S.A. | Lisbon | Lisbon District | Recruiting |
| Unidade Local De Saude De Santo Antonio E.P.E. | Porto | Porto District | 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 |
+ 6 more sites — see the full list on the official registry below.
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 Spain