Phase III Study Comparing Mannitol 100g and Plenvu for Same-Day Bowel Preparation Before Elective Colonoscopy

What this Trial Is About

Researchers are evaluating the effectiveness and safety of bowel cleansing using 100 g Mannitol compared to the standard Plenvu same-day dosing regimen for people undergoing elective colonoscopy. This Phase III international study aims to determine if Mannitol is not worse than Plenvu in preparing the bowel for colonoscopy. The study is randomized, parallel-group, and endoscopist-blinded to ensure unbiased results. Participants are randomly assigned to one of two groups. One group will self-administer a single dose of 100 g Mannitol dissolved in 1 liter of water within 45 minutes on the day of colonoscopy. The other group will follow a split-dose regimen of Plenvu the same day, involving dissolving doses in water and drinking specified amounts over a period with a waiting time between doses. Both groups consume a total of 2 liters of preparation liquid. During the study, participants will undergo colonoscopy within 28 days of signing consent, where bowel cleansing quality will be assessed using the Boston Bowel Preparation Scale. Researchers will also measure adenoma detection rate, cecal intubation rate, repeat colonoscopy rates, and presence of colonic bubbles. Participants must complete the entire study and follow instructions. Safety and patient acceptance will also be monitored throughout the trial period.

Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)