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PLENVU versus sodium picosulfate bowel preparation for children having a colonoscopy

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)

Phase 3 Interventional Norgine · NCT07218523

This trial will try whether PLENVU® cleans the bowel as well and is as safe and tolerable as sodium picosulfate in children under 18 preparing for a colonoscopy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment212 (estimated)
Ages1 Year to 17 Years
SexAll
SponsorNorgine Industry-sponsored
Locations40 sites (Edegem, Antwerp and 39 other locations)
Trial IDNCT07218523 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 to under 18 years who require a colonoscopy, weigh at least 10 kg (with ages 1 to <4 years above the 10th weight percentile), are not breastfeeding or pregnant, and can be admitted to the clinical research unit for dosing and the procedure.

Not a fit: Patients with recent severe constipation requiring repeated interventions, known or suspected GI obstruction, ileus, perforation, toxic or ischemic colitis, megacolon, or those who cannot take the oral preparations or are breastfeeding/pregnant are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the intervention could offer a more effective or better-tolerated bowel preparation option for children, improving colon visualization and diagnostic accuracy.

How similar studies have performed: Low-volume bowel preparations like PLENVU® have shown good efficacy and tolerability in adults, but randomized pediatric data are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Edegem, Antwerp and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bowel Cleansing Prior to Clinical ProceduresColonoscopyPaediatricHarefield Cleansing ScaleBoston Bowel Preparation ScalePlenvuPolyethylene GlycolBowel Cleansing
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.