Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel. Clinical Trial
Official title:
Multicenter Endoscopist-blinded Randomized Parallel-group Comparative Study to Assess Efficacy, Safety and Tolerance of Morning-only Dosing Compared to Control Split-dosing With Nocturnal Pause in MOVIPREP® Bowel Preparation Prior to Colonoscopy
To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.
All participants enrolled to the study will be allocated to one of two arms. Patients of the
experimental morning-only regimen arm will prepare and take MOVIPREP® solution in the full
dose - 2 litres of MOVIPREP® preparation in the early morning on the day of the colonoscopy
clinical procedure. Participants in the standard split-dose regimen arm will prepare and
take MOVIPREP® solution in split doses - ½ of dose (1 litre) the evening before + ½ of dose
(1 litre) of MOVIPREP® preparation in the morning of the day of the colonoscopy.
The study consists of three visits. Participation in the study lasts no more than 11 days; 3
days as minimum.
There is no follow-up period planned except in case of any adverse events (AEs) when the
follow-up period will last until the participant has recovered or until all AE-related
queries for the participant have been resolved.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment