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.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure").
Christian Ell, Prof Dr med
Dr. Horst Schmidt Kliniken GmbH
Germany: Federal Institute for Drugs and Medical Devices
NRL 994-01/2004 (HSG)