Actively Recruiting
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
Led by Norgine · Updated on 2026-01-21
212
Participants Needed
40
Research Sites
53 weeks
Total Duration
On this page
Sponsors
N
Norgine
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
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Trial Site Locations
Total: 40 locations
1
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerp, Belgium, 2650
Not Yet Recruiting
2
Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
Jette, Brussels Capital, Belgium, 1090
Not Yet Recruiting
3
Clinique CHC MontLegia
Alleur, Liege, Belgium, 4000
Not Yet Recruiting
4
Krankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin
Regensburg, Bavaria, Germany, 93049
Not Yet Recruiting
5
Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Allgemeine Paediatrie
Münster, North Rhine-Westphalia, Germany, 48149
Not Yet Recruiting
6
Helios Uniklinikum Wuppertal
Wuppertal, North Rhine-Westphalia, Germany, 42283
Not Yet Recruiting
7
Universitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR
Mainz, Rhineland-Palatinate, Germany, 55131
Not Yet Recruiting
8
Charité Universitätsmedizin Berlin
Berlin, Germany, 049006
Not Yet Recruiting
9
Semmelweis Egyetem Gyermekgyogyaszati Klinika Bokay Utcai Reszleg
Budapest, Hungary, 1083
Not Yet Recruiting
10
Heim Pal Orszagos Gyermekgyogyaszati Intezet
Budapest, Hungary, 1089
Not Yet Recruiting
11
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, Hungary, 3526
Not Yet Recruiting
12
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Firenze, Italy, 50139
Not Yet Recruiting
13
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Italy, 24127
Not Yet Recruiting
14
Azienda Ospedaliera Universitaria Gaetano Martino
Messina, Italy, 98124
Not Yet Recruiting
15
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
Milan, Italy, 20122
Not Yet Recruiting
16
Azienda Ospedaliera Universitaria Federico II - Pediatria Generale
Naples, Italy, 80131
Not Yet Recruiting
17
AOU Università degli studi della Campania Luigi Vanvitelli, Policlinico di Napoli - Pediatria
Naples, Italy, 80138
Not Yet Recruiting
18
Azienda Ospealiero Universitaria Policlinico Umberto I
Roma, Italy, 00161
Not Yet Recruiting
19
Policlinico Gemelli - Endoscopia Digestiva Chirurgica
Roma, Italy, 00168
Not Yet Recruiting
20
Azienda Ospedaliero-Universitaria Sant'Andrea - Pediatria
Roma, Italy, 00189
Not Yet Recruiting
21
Amphia Hospital - Pediatrics
Breda, North Brabant, Netherlands, 4818 CK
Not Yet Recruiting
22
Amsterdam UMC - Pediatrics
Amsterdam, North Holland, Netherlands, 1105 AZ
Not Yet Recruiting
23
Isala Klinieken
Zwolle, Overijssel, Netherlands, 8025 AB
Not Yet Recruiting
24
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu - Oddzial Pediatrii i Gastroenterologii
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Not Yet Recruiting
25
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Lesser Poland Voivodeship, Poland, 30-663
Not Yet Recruiting
26
Instytut "Pomnik - Centrum Zdrowia Dziecka" - Oddzial Gastroenterologii, Hepatologii, Zaburzen Odzywiania i Pediatrii
Warsaw, Masovian Voivodeship, Poland, 04-730
Not Yet Recruiting
27
Uniwersytecki Dzieciecy Szpital Kliniczny Imienia Ludwika Zamenhofa w Bialymstoku - Klinika Pediatrii, Gastroenterologii, Hepato
Bialystok, Podlaskie Voivodeship, Poland, 15-274
Not Yet Recruiting
28
Gdanski Uniwersytet Medyczny (GUMed) - Katedra i Klinika Pediatrii, Gastroenterologii, Alergologii i Zywienia Dzieci
Gdansk, Pomeranian Voivodeship, Poland, 80-803
Not Yet Recruiting
29
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanislawa Szyszko SUM w Katowicach Oddzial Gastroenterologii i Hepatolog
Zabrze, Silesian Voivodeship, Poland, 41-800
Not Yet Recruiting
30
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, Spain, 15405
Not Yet Recruiting
31
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120
Not Yet Recruiting
32
Parc Tauli Hospital Universitarli
Sabadell, Barcelona, Spain, 08208
Not Yet Recruiting
33
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Not Yet Recruiting
34
Hospital Materno Infantil de Málaga
Málaga, Spain, 29011
Not Yet Recruiting
35
NHS Lothian - Royal Hospital for Children & Young People
Edinburgh, Edinburgh, City of, United Kingdom, EH16 4TJ
Not Yet Recruiting
36
King's College Hospital NHS Foundation Trust
London, York, United Kingdom, SE5 9RS
Not Yet Recruiting
37
Birmingham Women's and Children's NHS Foundation Trust - Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Actively Recruiting
38
Barts Health NHS Trust
London, United Kingdom, E1 1FR
Actively Recruiting
39
Great North Children's Hospital - Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Not Yet Recruiting
40
Sheffield Children's NHS Foundation Trust - Sheffield Children's Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
Research Team
L
Lucy Clayton
CONTACT
A
Annabel Rigg
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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