Study to Assess the Tolerability, Safety and Efficacy of an Adapted Gut Cleansing Solution in Routine Colon Cleansing Prior to Colonoscopies
It is particularly important that thorough gut cleansing is achieved prior to the colonoscopy for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E) solutions are well established as safe and effective agents for gut cleansing and Norgine has successfully developed a low volume (2 litre) PEG+E gut lavage solution. The efficacy and safety of this solution is similar to the standard 4 litre PEG+E, but with improved patient acceptance.
Tolerance, acceptability and satisfaction with the cleansing agent plays an important role in subjects' compliance with gut preparation procedure. The study medication NRL0706 is identical to the PEG+E-containing gut lavage solution commonly used in clinical practice, with the exception that the flavour has been modified from lemon to orange. This study is to investigate the tolerability, acceptability, safety and efficacy of a single dose of NRL0706 (MOVIPREP Orange) in subjects without gastrointestinal symptoms undergoing colonoscopy for colon cancer screening.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Open Study to Assess the Tolerability, Safety and Efficacy of an Adapted 2 Litre Gut Cleansing Solution (NRL0706) in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumour Screening.|
- Overall Acceptance on VAS (100mm) rating [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Tolerance on five-point VRS [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Taste Evaluation on VAS (100mm) rating [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Acceptability rated by compliance, four-point VRS and VAS (100mm) rating [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Efficacy on five-grade scale for pre-defined colon areas [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: Moviprep Orange
All patients receive 2 litres of NRL0706 solution.
Patients receive 1 litre of NRL0706 solution followed by 0.5 litre of clear liquid during the afternoon/evening prior to colonoscopy. Patients receive 1 litre of 0706 solution followed by 0.5 litre of clear liquid during the morning of colonoscopy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251237
|Aschaffenburg, Germany, D-63739|
|Principal Investigator:||Wolfgang Fischbach, Prof Dr med||Klinikum Aschaffenburg-Alzenau|