Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®
brief 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 .
detailed 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: 18 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
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