Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep® — SATISFACTION  

Elective Colonoscopy Clinical Trial

Official title: Efficacy and Safety of mAnniTol in Bowel Preparation: Assessment of Adequacy and Presence of Intestinal levelS of Hydrogen and Methane During Elective Colonoscopy aFter mAnnitol or Standard Split 2-liter Polyethylene Glycol Solution Plus asCorbaTe - a Phase II/III, International, Multicentre, Randomized, Parallel-group, endoscOpist-bliNded, Dose-finding/Non-inferiority Study - SATISFACTION

Status Completed

Clinical Trial Summary

The purpose of this dose finding/comparative efficacy study is to first single out the most appropriate dose of mannitol for bowel preparation (phase II) and, subsequently, demonstrate the non-inferiority of the efficacy of single dose mannitol vs standard split 2L PEG ASC (Moviprep®) (phase III) in bowel preparation for colonoscopy .

Clinical Trial Description

Study Start and Study Completion dates relative to the Phase II/III are reported here:

Phase II (Patients n. 183)

• Date of first enrolment: 22 June 2020

• Date LPLV: 12 November 2020

Phase III (Patients n. 703)

• Date of first enrolment: 2 March 2021

• Date LPLV: 16 July 2021

Date on which the study was entered in the EudraCT database: 13 October 2020 ;

Related Conditions & MeSH terms

• Elective Colonoscopy

• NCT number: NCT04759885
• Study type: Interventional
• Source: NTC srl
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 18, 2020
• Completion date: July 16, 2021