Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07218523

PHASE3

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

Sponsor: Norgine

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

1 Year - 17 Years

Study Type

INTERVENTIONAL

Enrollment

212

Start Date

2025-12-29

Completion Date

2027-01-06

Last Updated

2026-01-21

Healthy Volunteers

Conditions

Bowel Cleansing Prior to Clinical Procedures

Interventions

DRUG

PLENVU®

PLENVU® will be administered as an oral solution.

DRUG

Sodium picosulfate

Sodium picosulfate will be administered as an oral solution.

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.

Locations (40)

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Antwerp, Belgium

Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)

Jette, Brussels Capital, Belgium

Clinique CHC MontLegia

Alleur, Liege, Belgium

Krankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin

Regensburg, Bavaria, Germany

Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Allgemeine Paediatrie

Münster, North Rhine-Westphalia, Germany

Helios Uniklinikum Wuppertal

Wuppertal, North Rhine-Westphalia, Germany

Universitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR

Mainz, Rhineland-Palatinate, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany

Semmelweis Egyetem Gyermekgyogyaszati Klinika Bokay Utcai Reszleg

Budapest, Hungary

Heim Pal Orszagos Gyermekgyogyaszati Intezet

Budapest, Hungary

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz

Miskolc, Hungary

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Firenze, Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Italy

Azienda Ospedaliera Universitaria Gaetano Martino

Messina, Italy

Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda

Milan, Italy

Azienda Ospedaliera Universitaria Federico II - Pediatria Generale

Naples, Italy

AOU Università degli studi della Campania Luigi Vanvitelli, Policlinico di Napoli - Pediatria

Naples, Italy

Azienda Ospealiero Universitaria Policlinico Umberto I

Roma, Italy

Policlinico Gemelli - Endoscopia Digestiva Chirurgica

Roma, Italy

Azienda Ospedaliero-Universitaria Sant'Andrea - Pediatria

Roma, Italy

Amphia Hospital - Pediatrics

Breda, North Brabant, Netherlands

Amsterdam UMC - Pediatrics

Amsterdam, North Holland, Netherlands

Isala Klinieken

Zwolle, Overijssel, Netherlands

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu - Oddzial Pediatrii i Gastroenterologii

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Instytut "Pomnik - Centrum Zdrowia Dziecka" - Oddzial Gastroenterologii, Hepatologii, Zaburzen Odzywiania i Pediatrii

Warsaw, Masovian Voivodeship, Poland

Uniwersytecki Dzieciecy Szpital Kliniczny Imienia Ludwika Zamenhofa w Bialymstoku - Klinika Pediatrii, Gastroenterologii, Hepato

Bialystok, Podlaskie Voivodeship, Poland

Gdanski Uniwersytet Medyczny (GUMed) - Katedra i Klinika Pediatrii, Gastroenterologii, Alergologii i Zywienia Dzieci

Gdansk, Pomeranian Voivodeship, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanislawa Szyszko SUM w Katowicach Oddzial Gastroenterologii i Hepatolog

Zabrze, Silesian Voivodeship, Poland

Complejo Hospitalario Universitario de Ferrol

Ferrol, A Coruña, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Parc Tauli Hospital Universitarli

Sabadell, Barcelona, Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

Hospital Materno Infantil de Málaga

Málaga, Spain

NHS Lothian - Royal Hospital for Children & Young People

Edinburgh, Edinburgh, City of, United Kingdom

King's College Hospital NHS Foundation Trust

London, York, United Kingdom

Birmingham Women's and Children's NHS Foundation Trust - Birmingham Children's Hospital

Birmingham, United Kingdom

Barts Health NHS Trust

London, United Kingdom

Great North Children's Hospital - Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

Sheffield Children's NHS Foundation Trust - Sheffield Children's Hospital

Sheffield, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (40)