NCT00322062

MOVIPREP® Versus NaP Pivotal Phase III Study

A Prospective Randomised Single-Blinded Multicentric and Pivotal Phase III Study Comparing the Efficacy, Safety and Acceptability of a New 2 Litres Gut Lavage Solution NRL994 Versus a Sodium Phosphate Solution for Colonoscopy Preparation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market. Efficacy of each bowel preparation, safety and acceptability will be assessed.

Detailed description

Multicentric (15 centres), prospective, randomised, single-blinded phase III pivotal study in patients undergoing a colonoscopy. Gut cleansing will be performed using 2 litres of NRL994 gut lavage solution with 1 litre (or more) of extra clear liquids or 2 x 45 ml of a sodium phosphate solution plus 2 litres (or more) of extra clear liquids the day before colonoscopy. Patients requiring a morning colonoscopy who fulfil the inclusion criteria, will be randomised. One of the two tested products will be delivered by a pharmacist, blindly from the gastroenterologist. The assigned product will be taken the day before the coloscopy according to the information leaflet. Efficacy of the two tested preparations will be measured on video-tape record of each colonoscopy by a final grading i.e. "the overall quality of colonoscopy prep" by an gastroenterologist expert. A standardised patient questionnaire administered by a nurse on the morning before colonoscopy will assess clinical tolerance and acceptability (satisfaction) of the prep. A baseline blood sampling will be withdrew before intake of the preparation and one more blood sample will be performed after the intake on the morning, before the coloscopy. After the coloscopy, as the gastroenterologist gives the result of the coloscopy , a last visit is performed.

Conditions

• Colonoscopy

Interventions

Type	Name	Description
DRUG	macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate	2L gut lavage solution
DRUG	Sodium Phosphate Solution	1 x 45ml solution, BID

Timeline

• Start date: 2002-04-01
• Completion: 2003-03-01
• First posted: 2006-05-04
• Last updated: 2008-04-16

Locations

18 sites across 1 country: France