LONDON, May 24, 2016 /PRNewswire/ --
- Study met both primary endpoints demonstrating non-inferiority in overall bowel
cleansing and superiority in 'Excellent plus Good' cleansing of the ascending colon
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Norgine B.V. today announced new positive data from the phase III MORA study for NER1006 (1 litre PEG and ascorbate bowel preparation) versus standard 2 litre PEG with ascorbate. The study met both primary endpoints showing that when administered as either a 2-day overnight or 1-day morning split-dosing regimen, and compared to 2L PEG, NER1006 was:
- Non-inferior in achieving overall bowel cleansing
- Non-inferior and superior in achieving 'Excellent plus Good' cleansing of the
In addition, the study showed that as a 2-day overnight or 1-day morning split-dosing regimen, NER1006 was non-inferior in detecting adenomas and polyps in the ascending and overall colon and as a 2-day overnight split-dosing regimen, it demonstrated a superior polyp detection rate in the ascending colon.
The overall tolerability and safety profile of NER1006 was comparable to that of 2L PEG. Treatment related adverse events were mild or moderate in severity and reflected the expected safety profile of the respective treatments.
The threshold for statistical significance in this study was P