Colonoscopy Clinical Trials

Clinical trials related to Colonoscopy Procedure

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)

Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Clinique CHC MontLegia
NOT_YET_RECRUITING
Alleur
Universitair Ziekenhuis Antwerpen (UZA)
NOT_YET_RECRUITING
Edegem
Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
NOT_YET_RECRUITING
Jette
Germany
Charité Universitätsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Universitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR
NOT_YET_RECRUITING
Mainz
Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Allgemeine Paediatrie
NOT_YET_RECRUITING
Münster
Krankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin
NOT_YET_RECRUITING
Regensburg
Helios Uniklinikum Wuppertal
NOT_YET_RECRUITING
Wuppertal
Hungary
Heim Pal Orszagos Gyermekgyogyaszati Intezet
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem Gyermekgyogyaszati Klinika Bokay Utcai Reszleg
NOT_YET_RECRUITING
Budapest
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
NOT_YET_RECRUITING
Miskolc
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
NOT_YET_RECRUITING
Bergamo
Azienda Ospedaliera Universitaria Meyer IRCCS
NOT_YET_RECRUITING
Florence
Azienda Ospedaliera Universitaria Gaetano Martino
NOT_YET_RECRUITING
Messina
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
NOT_YET_RECRUITING
Milan
AOU Università degli studi della Campania Luigi Vanvitelli, Policlinico di Napoli - Pediatria
NOT_YET_RECRUITING
Naples
Azienda Ospedaliera Universitaria Federico II - Pediatria Generale
NOT_YET_RECRUITING
Naples
Azienda Ospealiero Universitaria Policlinico Umberto I
NOT_YET_RECRUITING
Roma
Azienda Ospedaliero-Universitaria Sant'Andrea - Pediatria
NOT_YET_RECRUITING
Roma
Policlinico Gemelli - Endoscopia Digestiva Chirurgica
NOT_YET_RECRUITING
Roma
Netherlands
Amsterdam UMC - Pediatrics
NOT_YET_RECRUITING
Amsterdam
Amphia Hospital - Pediatrics
NOT_YET_RECRUITING
Breda
Isala Klinieken
NOT_YET_RECRUITING
Zwolle
Poland
Uniwersytecki Dzieciecy Szpital Kliniczny Imienia Ludwika Zamenhofa w Bialymstoku - Klinika Pediatrii, Gastroenterologii, Hepato
NOT_YET_RECRUITING
Bialystok
Gdanski Uniwersytet Medyczny (GUMed) - Katedra i Klinika Pediatrii, Gastroenterologii, Alergologii i Zywienia Dzieci
NOT_YET_RECRUITING
Gdansk
Uniwersytecki Szpital Dzieciecy w Krakowie
NOT_YET_RECRUITING
Krakow
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu - Oddzial Pediatrii i Gastroenterologii
NOT_YET_RECRUITING
Torun
Instytut Pomnik - Centrum Zdrowia Dziecka - Oddzial Gastroenterologii, Hepatologii, Zaburzen Odzywiania i Pediatrii
NOT_YET_RECRUITING
Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanislawa Szyszko SUM w Katowicach Oddzial Gastroenterologii i Hepatolog
NOT_YET_RECRUITING
Zabrze
Spain
Complejo Hospitalario Universitario de Ferrol
NOT_YET_RECRUITING
Ferrol
Hospital Infantil Universitario Niño Jesús
NOT_YET_RECRUITING
Madrid
Hospital Materno Infantil de Málaga
NOT_YET_RECRUITING
Málaga
Hospital Universitario Son Espases
NOT_YET_RECRUITING
Palma De Mallorca
Parc Tauli Hospital Universitarli
NOT_YET_RECRUITING
Sabadell
United Kingdom
Birmingham Women's and Children's NHS Foundation Trust - Birmingham Children's Hospital
RECRUITING
Birmingham
NHS Lothian - Royal Hospital for Children & Young People
NOT_YET_RECRUITING
Edinburgh
Barts Health NHS Trust
RECRUITING
London
King's College Hospital NHS Foundation Trust
NOT_YET_RECRUITING
London
Great North Children's Hospital - Royal Victoria Infirmary
NOT_YET_RECRUITING
Newcastle Upon Tyne
Sheffield Children's NHS Foundation Trust - Sheffield Children's Hospital
RECRUITING
Sheffield
Contact Information
Primary
Lucy Clayton
LClayton@norgine.com
+441895826669
Backup
Annabel Rigg
ARigg@norgine.com
+441895453624
Time Frame
Start Date: 2025-12-29
Estimated Completion Date: 2027-01-06
Participants
Target number of participants: 212
Treatments
Experimental: PLENVU®
Participants will receive PLENVU® in a 2-day split dosing regimen.
Active_comparator: Sodium picosulfate
Participants will receive sodium picosulfate in a 2-day split dosing regimen according to the local label.
Related Therapeutic Areas
Colonoscopy
Endoscopy
Sponsors
Leads: Norgine
Collaborators: Parexel

This content was sourced from clinicaltrials.gov

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