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 (41) 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
RECRUITING
Alleur
Universitair Ziekenhuis Antwerpen (UZA)
RECRUITING
Edegem
Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
RECRUITING
Jette
Germany
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Universitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR
RECRUITING
Mainz
Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Allgemeine Paediatrie
RECRUITING
Münster
Krankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin
RECRUITING
Regensburg
Helios Uniklinikum Wuppertal
RECRUITING
Wuppertal
Hungary
Heim Pal Orszagos Gyermekgyogyaszati Intezet
RECRUITING
Budapest
Semmelweis Egyetem Gyermekgyogyaszati Klinika Bokay Utcai Reszleg
RECRUITING
Budapest
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
RECRUITING
Miskolc
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
NOT_YET_RECRUITING
Bergamo
Azienda Ospedaliera Universitaria Meyer IRCCS
RECRUITING
Florence
Azienda Ospedaliera Universitaria Gaetano Martino
RECRUITING
Messina
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
RECRUITING
Milan
AOU Università degli studi della Campania Luigi Vanvitelli, Policlinico di Napoli - Pediatria
NOT_YET_RECRUITING
Naples
Azienda Ospedaliera di Rilievo Nazionale (AORN) Santobono Pausilipon
NOT_YET_RECRUITING
Naples
Azienda Ospedaliera Universitaria Federico II - Pediatria Generale
RECRUITING
Naples
Azienda Ospealiero Universitaria Policlinico Umberto I
RECRUITING
Roma
Azienda Ospedaliero-Universitaria Sant'Andrea - Pediatria
WITHDRAWN
Roma
Policlinico Gemelli - Endoscopia Digestiva Chirurgica
RECRUITING
Roma
Netherlands
Amsterdam UMC - Pediatrics
RECRUITING
Amsterdam
Amphia Hospital - Pediatrics
RECRUITING
Breda
Isala Klinieken
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
RECRUITING
Gdansk
Uniwersytecki Szpital Dzieciecy w Krakowie
NOT_YET_RECRUITING
Krakow
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu - Oddzial Pediatrii i Gastroenterologii
RECRUITING
Torun
Instytut Pomnik - Centrum Zdrowia Dziecka - Oddzial Gastroenterologii, Hepatologii, Zaburzen Odzywiania i Pediatrii
RECRUITING
Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanislawa Szyszko SUM w Katowicach Oddzial Gastroenterologii i Hepatolog
RECRUITING
Zabrze
Spain
Complejo Hospitalario Universitario de Ferrol
RECRUITING
Ferrol
Hospital Infantil Universitario Niño Jesús
RECRUITING
Madrid
Hospital Materno Infantil de Málaga
RECRUITING
Málaga
Hospital Universitario Son Espases
RECRUITING
Palma De Mallorca
Parc Tauli Hospital Universitarli
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
RECRUITING
Edinburgh
Barts Health NHS Trust
RECRUITING
London
King's College Hospital NHS Foundation Trust
RECRUITING
London
Great North Children's Hospital - Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
Sheffield Children's NHS Foundation Trust - Sheffield Children's Hospital
RECRUITING
Sheffield
Contact Information
Primary
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
Endoscopy
Colonoscopy
Sponsors
Leads: Norgine
Collaborators: Parexel

This content was sourced from clinicaltrials.gov

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