Study to Assess the Tolerability, Safety and Efficacy of an Adapted Gut Cleansing Solution in Routine Colon Cleansing Prior to Colonoscopies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01251237|
Recruitment Status : Completed
First Posted : December 1, 2010
Last Update Posted : December 1, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: NRL0706||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||March 2010|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
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.
- Overall Acceptance on VAS (100mm) rating [ Time Frame: 12 hours ]
- Tolerance on five-point VRS [ Time Frame: 12 hours ]
- Taste Evaluation on VAS (100mm) rating [ Time Frame: 12 hours ]
- Acceptability rated by compliance, four-point VRS and VAS (100mm) rating [ Time Frame: 12 hours ]
- Efficacy on five-grade scale for pre-defined colon areas [ Time Frame: 12 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251237
|Aschaffenburg, Germany, D-63739|
|Principal Investigator:||Wolfgang Fischbach, Prof Dr med||Klinikum Aschaffenburg-Alzenau|