Actively Recruiting
Phase 3 Study Comparing Oral PLENVU4 and Sodium Picosulfate for Bowel Cleansing in Children Aged 1 to Under 18 Before Colonoscopy
Led by Norgine · Updated on 2026-05-27
212
Participants Needed
41
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and tolerability of PLENVU4 compared to sodium picosulfate for bowel cleansing in children under 18 who need a colonoscopy. Colonoscopy is important for diagnosing and managing various gastrointestinal conditions in pediatric patients, and good bowel preparation is essential for clear viewing during the procedure. Participants will be randomly assigned to receive either PLENVU4 or sodium picosulfate, both given as oral solutions in a 2-day split dosing schedule. The study includes a screening period up to 28 days before treatment. On Day 1, participants are admitted to the Clinical Research Unit to receive the intervention and stay through Day 2 to complete the colonoscopy. A safety follow-up contact or visit occurs around Day 9. During the study, researchers will assess bowel cleansing success using specific scales on Day 2, record any adverse events through the safety follow-up, and evaluate participants responses to the treatments. The total participation spans from screening through to safety monitoring about a week after the procedure.
CONDITIONS
Brief Title
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
Research Team
A
Annabel Rigg
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