CLARITYÉtude sur l'efficacité du nettoyage intestinal de PLENVU® dans la préparation à la coloscopie pédiatrique

Date de début de l'étude : 29 décembre 2025

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.