A Phase 2 interventional study of NRL0706 in Colon Cancer, sponsored by Norgine. Completed at 1 site in Germany. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-01.
Sponsored by Norgine · Phase 2, Interventional, and Diagnostic
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 120 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Norgine is the lead sponsor of 52 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients receive 2 litres of NRL0706 solution.
Drug: NRL0706
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
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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