PLENVU versus sodium picosulfate bowel preparation for children having a colonoscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicentre, randomized (1:1), active-controlled Phase 3 trial comparing PLENVU® to sodium picosulfate using a two-day split dosing regimen in paediatric participants scheduled for colonoscopy. Participants are admitted to a clinical research unit on Day 1 for intervention administration and remain for the colonoscopy on Day 2, with a safety follow-up by call or visit around Day 9. Bowel cleansing success will be measured using standard scales (e.g., Harefield and Boston bowel preparation scales) along with safety and tolerability assessments. The trial is being conducted at three Belgian centres and includes screening up to 28 days prior to dosing.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universitair Ziekenhuis Antwerpen (UZA)
  Edegem, Antwerp, Belgium Recruiting
• Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
  Jette, Brussels Capital, Belgium Recruiting
• Clinique CHC MontLegia
  Alleur, Liege, Belgium Recruiting
• Clinical Hospital Centre Rijeka
  Rijeka, Primorje-Gorski Kotar County, Croatia Recruiting
• Krankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin
  Regensburg, Bavaria, Germany Recruiting
• Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Allgemeine Paediatrie
  Münster, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Study coordinator: Annabel Rigg
• Email: ARigg@norgine.com
• Phone: +441895453624

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.