NCT00427089

Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening

Parallel Group Comparison of the New 2 Liter Gut Cleansing Solution NRL 994 Versus Sodium Phosphate Preparation in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies

Detailed description

This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.

Conditions

• Colonoscopy

Interventions

Type	Name	Description
DRUG	Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate	2L gut lavage solution
DRUG	Sodium Phosphate solution (NaP)	45 ml solution; BID

Timeline

• Start date: 2004-09-01
• Completion: 2005-05-01
• First posted: 2007-01-26
• Last updated: 2008-04-16

Locations

12 sites across 1 country: Germany