NCT03742232

Study Comparing the Bowel Cleansing Efficacy of PLENVU® Versus SELG-ESSE® Using a 2-Day Split Dosing Regimen.

A Multicentre Randomized Parallel Group Phase IV Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of PLENVU® Versus SELG-ESSE® Using a 2-Day Split Dosing Regimen.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicentre randomized parallel group phase IV study comparing the bowel cleansing efficacy, safety and tolerability of PLENVU® (a 1 litre PEG Bowel Cleansing Solution) versus SELG-ESSE® (a 4 litre PEG Bowel Cleansing Solution) using a 2-Day Split Dosing Regimen.

Conditions

• Colon Polyp
• Colon Adenoma
• Colon Lesion

Interventions

Type	Name	Description
DRUG	PEG3350	PLENVU® supplied as two powder-for-oral-solution formulations. One formulation contains PEG3350, sodium sulphate and electrolytes, and the second formulation contains PEG3350, sodium ascorbate, ascorbic acid, and electrolytes. PLENVU® Administration: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
DRUG	Macrogol 4000	SELG-ESSE® supplied as powder-for-oral-solution containing PEG4000, simethicone, sodium sulphate and sodium bicarbonate, and electrolytes. SELG-ESSE® Administration: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).

Timeline

• Start date: 2018-10-31
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2018-11-15
• Last updated: 2020-08-27

Locations

5 sites across 1 country: Italy