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A Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation — NORMO  

Gastrointestinal Diseases Clinical Trial

Official title:
A Randomised, Multicentre, Single-Blind, Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation.

Clinical Trial Summary

Primary:

- To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to colonoscopy.

Secondary:

- To assess the safety of Moviprep® versus Colopeg®.

- To assess acceptability of Moviprep® versus Colopeg®.

Clinical Trial Description

Primary efficacy analysis will be performed on the ITT population. Secondary efficacy analysis will be performed on both ITT and PP sets. Results will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old) and provided in individual data listings.

Safety analysis will be performed on the safety set (ITT population). Safety data of all patients exposed will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old).

Acceptability analysis will be performed on the ITT population. Acceptability data of all patients will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00605228
Study type Interventional
Source Norgine
Contact
Status Completed
Phase Phase 4
Start date May 2007
Completion date December 2007
View Details
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