NCT00605228

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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®.

Detailed 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).

Conditions

• Gastrointestinal Diseases

Interventions

Type	Name	Description
DRUG	MOVIPREP	2L Drug
DRUG	COLOPEG	4L Drug

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2008-01-30
• Last updated: 2008-01-30

Locations

21 sites across 1 country: France