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

NCT07218523 | Recruiting Phase 3 DMC

• 2 other identifiers: NER1006-01/20252025-522046-42-00
• Study Type: interventional
• Target: 212
• Locations: 8 countries
• Sites: 40

Brief 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.

Conditions

Bowel Cleansing Prior to Clinical Procedures

Keywords

Colonoscopy; Paediatric; Harefield Cleansing Scale; Boston Bowel Preparation Scale; Plenvu; Polyethylene Glycol (PEG); Bowel Cleansing

Outcome Measures

Primary Outcomes (1)

• Percentage of participants achieving adequate bowel cleansing based on Boston Bowel Preparation Scale (BBPS)

  To describe the success rate of bowel cleansing in paediatric participants after administration of PLENVU® or sodium picosulfate as measured by the BBPS. The BBPS is a scoring system used to assess bowel cleanliness during colonoscopy. The scale ranges from 0 to 3, evaluating the three colonic segments (i.e. right colon, transverse colon, and left colon) where a score of 0 indicates an unprepared colon segment with mucosa not visible due to solid stool, and 3 indicates mucosa of colon segment seen well, with bowel cleansing success defined as a score of ≥2 in all three segments.

  Day 2

Secondary Outcomes (3)

• Percentage of participants achieving successful bowel cleansing based on Harefield Cleansing Scale (HCS)

  Day 2

• Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)

  From Screening (Day -28 to Day -1) to safety follow-up (Day 9 ± 2 days)

• Number of participants with a response on the Likert Scale

  Day 1 and Day 2

Study Arms (2)

PLENVU®

EXPERIMENTAL

Participants will receive PLENVU® in a 2-day split dosing regimen.

Drug: PLENVU®

Sodium picosulfate

ACTIVE COMPARATOR

Participants will receive sodium picosulfate in a 2-day split dosing regimen according to the local label.

Drug: Sodium picosulfate

Interventions

PLENVU® DRUG

PLENVU® will be administered as an oral solution.

Also known as: NER1006

PLENVU®

Sodium picosulfate DRUG

Sodium picosulfate will be administered as an oral solution.

Also known as: PICOPREP®, PICOLAX®

Sodium picosulfate

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Norgine: lead
• Parexel: collaborator

Study Sites (40)

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Antwerp, 2650, Belgium

NOT YET RECRUITING

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

Jette, Brussels Capital, 1090, Belgium

NOT YET RECRUITING

Clinique CHC MontLegia

Alleur, Liege, 4000, Belgium

NOT YET RECRUITING

Krankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin

Regensburg, Bavaria, 93049, Germany

NOT YET RECRUITING

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

Münster, North Rhine-Westphalia, 48149, Germany

NOT YET RECRUITING

Helios Uniklinikum Wuppertal

Wuppertal, North Rhine-Westphalia, 42283, Germany

NOT YET RECRUITING

Universitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR

Mainz, Rhineland-Palatinate, 55131, Germany

NOT YET RECRUITING

Charité Universitätsmedizin Berlin

Berlin, 049006, Germany

NOT YET RECRUITING

Semmelweis Egyetem Gyermekgyogyaszati Klinika Bokay Utcai Reszleg

Budapest, 1083, Hungary

NOT YET RECRUITING

Heim Pal Orszagos Gyermekgyogyaszati Intezet

Budapest, 1089, Hungary

NOT YET RECRUITING

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

Miskolc, 3526, Hungary

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Firenze, 50139, Italy

NOT YET RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, 24127, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Gaetano Martino

Messina, 98124, Italy

NOT YET RECRUITING

Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda

Milan, 20122, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Federico II - Pediatria Generale

Naples, 80131, Italy

NOT YET RECRUITING

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

Naples, 80138, Italy

NOT YET RECRUITING

Azienda Ospealiero Universitaria Policlinico Umberto I

Roma, 00161, Italy

NOT YET RECRUITING

Policlinico Gemelli - Endoscopia Digestiva Chirurgica

Roma, 00168, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria Sant'Andrea - Pediatria

Roma, 00189, Italy

NOT YET RECRUITING

Amphia Hospital - Pediatrics

Breda, North Brabant, 4818 CK, Netherlands

NOT YET RECRUITING

Amsterdam UMC - Pediatrics

Amsterdam, North Holland, 1105 AZ, Netherlands

NOT YET RECRUITING

Isala Klinieken

Zwolle, Overijssel, 8025 AB, Netherlands

NOT YET RECRUITING

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

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

NOT YET RECRUITING

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, Lesser Poland Voivodeship, 30-663, Poland

NOT YET RECRUITING

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

Warsaw, Masovian Voivodeship, 04-730, Poland

NOT YET RECRUITING

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

Bialystok, Podlaskie Voivodeship, 15-274, Poland

NOT YET RECRUITING

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

Gdansk, Pomeranian Voivodeship, 80-803, Poland

NOT YET RECRUITING

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

Zabrze, Silesian Voivodeship, 41-800, Poland

NOT YET RECRUITING

Complejo Hospitalario Universitario de Ferrol

Ferrol, A Coruña, 15405, Spain

NOT YET RECRUITING

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

NOT YET RECRUITING

Parc Tauli Hospital Universitarli

Sabadell, Barcelona, 08208, Spain

NOT YET RECRUITING

Hospital Infantil Universitario Niño Jesús

Madrid, 28009, Spain

NOT YET RECRUITING

Hospital Materno Infantil de Málaga

Málaga, 29011, Spain

NOT YET RECRUITING

NHS Lothian - Royal Hospital for Children & Young People

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

NOT YET RECRUITING

King's College Hospital NHS Foundation Trust

London, York, SE5 9RS, United Kingdom

NOT YET RECRUITING

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

Birmingham, B4 6NH, United Kingdom

RECRUITING

Barts Health NHS Trust

London, E1 1FR, United Kingdom

RECRUITING

Great North Children's Hospital - Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

NOT YET RECRUITING

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

Sheffield, S10 2TH, United Kingdom

RECRUITING

MeSH Terms

Interventions

Polyethylene Glycols; picosulfate sodium

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Lucy Clayton

CONTACT

+441895826669; LClayton@norgine.com

Annabel Rigg

CONTACT

+441895453624; ARigg@norgine.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The central reader colonoscopist will be blinded to the study intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2025
• First Posted: October 20, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): January 6, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

GB (6); ES (5); PL (6); HU (3); NL (3); BE (3); IT (9); DE (5)