At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Phase II: NTC015 low dose, Phase II: NTC015 medium dose, and 3 other interventions for Elective Colonoscopy. Completed, enrolled 886 participants across 35 sites in 4 countries.
Detailed 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 .
Study Details
Timeline
Interventions
Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
Participants should self administer the preparation within 60 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
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.