drugset / Trial / 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

NCT07218523

Phase 3 Recruiting 212 enrolled Norgine Parexel · collab
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2025-12-29
Primary completion
2027-01-06
Completion
2027-01-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Plenvu Unknown Oral
Comparator Sodium Picosulfate Unknown Oral

Indications

No indication recorded.