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.
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.
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.
Parallel
PLENVU®
DrugPLENVU® will be administered as an oral solution.
Sodium picosulfate
DrugSodium picosulfate will be administered as an oral solution.
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.
Percentage of participants achieving successful bowel cleansing based on Harefield Cleansing Scale (HCS)
To describe the success rate of bowel cleansing in paediatric participants after administration of PLENVU® or sodium picosulfate as measured by the HCS. The HCS is scoring system used to assess bowel cleanliness during colonoscopy. The scale ranges from 0 to 4 evaluating five segments (i.e. ascending colon, transverse colon, descending colon, sigmoid colon and rectum). The scores of the five segments will be the basis for a final grading of A, B, C, or D. Success is defined as a HCS grade of A or B.
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)
To determine the safety of PLENVU® as compared to sodium picosulfate in paediatric participants.
Number of participants with a response on the Likert Scale
To determine the tolerability, palatability and acceptability of PLENVU® as compared to sodium picosulfate. A paediatric 5-point Likert Scale will be used to assess the tolerability, palatability and acceptability. It uses a combination of facial expressions and simple language to make it easier for children to understand and respond.
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Norgine
Lead sponsor
Parexel
Collaborator
