NCT07465705

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

A Phase III, International, Multicenter, Randomized, Parallel-group, Endoscopist-blinded Non-inferiority Study of the Efficacy, Safety and Patient Acceptance of Mannitol Versus Plenvu® in Bowel Preparation for Elective Colonoscopy. CLEARWAY

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (estimated)
• Sponsor: NTC srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®.

Detailed description

Not provided

Conditions

• Elective Colonoscopy

Interventions

Type	Name	Description
DRUG	100g of Mannitol	Participants should self administer the preparation within 45 minutes, dissolving 100g of powder in 1L of water
DRUG	1L PEG-Asc	Self administration of the same day preparation according to the on lable instruction for use. The first dose consists in dissolving Dose 1 in 500ml of water, followed by another 500ml of water, all within 1 hour. After a 1 hour wait from the end of the first dose, the participant should self administer the Dose 2 consisting in dissolving one sachetA and one sachetB in 500ml of water, followed by another 500ml of water; all within 1 hour.

Timeline

• Start date: 2025-09-02
• Primary completion: 2026-03-31
• Completion: 2026-06-30
• First posted: 2026-03-12
• Last updated: 2026-03-13

Locations

18 sites across 5 countries: Belgium, Italy, Poland, Spain, Sweden