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New study aims to make colonoscopy prep easier for kids

NCT ID NCT07218523

Symptom relief Sponsor: Norgine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two bowel-cleansing medicines, PLENVU® and sodium picosulfate, in children aged 1 to 18 who need a colonoscopy. The goal is to see which one cleans the bowel better, is safer, and tastes better. Around 212 children will take part to help improve the procedure experience.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 212 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bowel cleansing prior to clinical procedures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    NOT_YET_RECRUITING

    Naples, Napoli, 80138, Italy

  • Amphia Hospital - Pediatrics

    RECRUITING

    Breda, North Brabant, 4818 CK, Netherlands

  • Amsterdam UMC - Pediatrics

    RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Azienda Ospealiero Universitaria Policlinico Umberto I

    RECRUITING

    Roma, Roma, 00161, Italy

  • Azienda Ospedaliera Universitaria Federico II - Pediatria Generale

    RECRUITING

    Naples, Napoli, 80131, Italy

  • Azienda Ospedaliera Universitaria Gaetano Martino

    RECRUITING

    Messina, Messina, 98124, Italy

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    RECRUITING

    Florence, Firenze, 50139, Italy

  • Azienda Ospedaliera di Rilievo Nazionale (AORN) Santobono Pausilipon

    NOT_YET_RECRUITING

    Naples, Napoli, 80129, Italy

  • Azienda Ospedaliero-Universitaria Sant'Andrea - Pediatria

    WITHDRAWN

    Roma, Roma, 00189, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    NOT_YET_RECRUITING

    Bergamo, Bergamo, 24127, Italy

  • Barts Health NHS Trust

    RECRUITING

    London, E1 1FR, United Kingdom

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

    RECRUITING

    Birmingham, B4 6NH, United Kingdom

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

    RECRUITING

    Miskolc, Miskolc, 3526, Hungary

  • Charité Universitätsmedizin Berlin

    RECRUITING

    Berlin, State of Berlin, 049006, Germany

  • Clinique CHC MontLegia

    RECRUITING

    Alleur, Liege, 4000, Belgium

  • Complejo Hospitalario Universitario de Ferrol

    RECRUITING

    Ferrol, A Coruña, 15405, Spain

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

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-803, Poland

  • Great North Children's Hospital - Royal Victoria Infirmary

    RECRUITING

    Newcastle upon Tyne, Newcastle Upon Tyne, NE1 4LP, United Kingdom

  • Heim Pal Orszagos Gyermekgyogyaszati Intezet

    RECRUITING

    Budapest, Budapest, 1089, Hungary

  • Helios Uniklinikum Wuppertal

    RECRUITING

    Wuppertal, North Rhine-Westphalia, 42283, Germany

  • Hospital Infantil Universitario Niño Jesús

    RECRUITING

    Madrid, Madrid, 28009, Spain

  • Hospital Materno Infantil de Málaga

    RECRUITING

    Málaga, Málaga, 29011, Spain

  • Hospital Universitario Son Espases

    RECRUITING

    Palma de Mallorca, Balearic Islands, 07120, Spain

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

    RECRUITING

    Warsaw, Masovian Voivodeship, 04-730, Poland

  • Isala Klinieken

    RECRUITING

    Zwolle, Overijssel, 8025 AB, Netherlands

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, York, SE5 9RS, United Kingdom

  • Krankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin

    RECRUITING

    Regensburg, Bavaria, 93049, Germany

  • NHS Lothian - Royal Hospital for Children & Young People

    RECRUITING

    Edinburgh, Edinburgh, City of, EH16 4TJ, United Kingdom

  • Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda

    RECRUITING

    Milan, Milano, 20122, Italy

  • Parc Tauli Hospital Universitarli

    RECRUITING

    Sabadell, Barcelona, 08208, Spain

  • Policlinico Gemelli - Endoscopia Digestiva Chirurgica

    RECRUITING

    Roma, Roma, 00168, Italy

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

    RECRUITING

    Zabrze, Silesian Voivodeship, 41-800, Poland

  • Semmelweis Egyetem Gyermekgyogyaszati Klinika Bokay Utcai Reszleg

    RECRUITING

    Budapest, Budapest, 1083, Hungary

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

    RECRUITING

    Sheffield, Sheffield, S10 2TH, United Kingdom

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

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitair Ziekenhuis Antwerpen (UZA)

    RECRUITING

    Edegem, Antwerp, 2650, Belgium

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

    RECRUITING

    Jette, Brussels Capital, 1090, Belgium

  • Universitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

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

    NOT_YET_RECRUITING

    Bialystok, Podlaskie Voivodeship, 15-274, Poland

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    NOT_YET_RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-663, Poland

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

    RECRUITING

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

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