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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicentre, active-controlled study in which the participants will be randomised 1:1 into one of two treatment groups - PLENVU® or sodium picosulfate in a 2-day split dosing regimen. The study will include - 1. A Screening Period of up to 28 days (Day -28 to Day -1). 2. A Treatment Period (Day 1 to Day 2) - Participants will be randomised to receive either PLENVU® or sodium picosulfate. Participants will be admitted into the Clinical Research Unit (CRU) on Day 1 and will remain in the CRU for the duration of study intervention administration (Day 1 and Day 2) and colonoscopy (Day 2). Participants will be discharged on Day 2 following the colonoscopy and evaluation of colon cleansing. 3. A safety follow-up call or CRU visit (Day 9 ± 2 days).

Conditions

• Bowel Cleansing Prior to Clinical Procedures

Interventions

Type	Name	Description
DRUG	PLENVU®	PLENVU® will be administered as an oral solution.
DRUG	Sodium picosulfate	Sodium picosulfate will be administered as an oral solution.

Timeline

• Start date: 2025-12-29
• Primary completion: 2027-01-06
• Completion: 2027-01-06
• First posted: 2025-10-20
• Last updated: 2026-01-21

Locations

40 sites across 8 countries: Belgium, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom