Colon Cancer Clinical Trial
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.
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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