NCT04759885

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

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 886 (actual)
• Sponsor: NTC srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Elective Colonoscopy

Interventions

Type	Name	Description
DRUG	Phase II: NTC015 low dose	Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
DRUG	Phase II: NTC015 medium dose	Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
DRUG	Phase II: NTC015 high dose	Participants should self administer the preparation within 60 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
DRUG	Phase III: NTC015 selected dose	Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
DRUG	Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC)	The instructions for product administration are followed according to the Summary of Product Characteristics. One treatment consists of two litres of Moviprep® taken according to split-dose regimen. The first litre of Moviprep® is prepared by dissolving one sachet A and one sachet B together in water to make one litre of solution. The reconstituted solution must be drunk over a period of one to two hours the evening before colonoscopy. About half a litre of clear liquid should be drunk in the next hour to prevent dehydration according to local practice at the centre. This process should be repeated with a second litre of Moviprep® prepared by dissolving one sachet A and one sachet B together in water to make one litre of solution in the early morning of the day of the procedure.

Timeline

• Start date: 2020-06-18
• Primary completion: 2021-07-16
• Completion: 2021-07-16
• First posted: 2021-02-18
• Last updated: 2025-12-08
• Results posted: 2025-12-08

Locations

35 sites across 4 countries: France, Germany, Italy, Russia