NCT07218523 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
| NCT ID | NCT07218523 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Norgine |
| Condition | Bowel Cleansing Prior to Clinical Procedures |
| Study Type | INTERVENTIONAL |
| Enrollment | 212 participants |
| Start Date | 2025-12-29 |
| Primary Completion | 2027-01-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 212 participants in total. It began in 2025-12-29 with a primary completion date of 2027-01-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07218523 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 17 Years, studying Bowel Cleansing Prior to Clinical Procedures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07218523 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 212 participants.
Is NCT07218523 currently recruiting?
Yes, NCT07218523 is actively recruiting participants. Contact the research team at ARigg@norgine.com for enrollment information.
Where is the NCT07218523 trial being conducted?
This trial is being conducted at Edegem, Belgium, Jette, Belgium, Alleur, Belgium, Regensburg, Germany and 11 additional locations.
Who is sponsoring the NCT07218523 clinical trial?
NCT07218523 is sponsored by Norgine. The trial plans to enroll 212 participants.