Phase III MORA trial of Plenvu in bowel preparation published in Endoscopy.- Norgine.
Norgine announced that results from the Plenvu (polyethylene glycol based bowel preparation) Phase III MORA trial were published in ENDOSCOPY, a monthly peer-reviewed medical journal on behalf of the European Society of Gastrointestinal Endoscopy. The MORA trial, a European Phase III study in adults, was designed to evaluate the efficacy and safety of Plenvu compared to MOVIPREP using a 2-day evening / morning split-dosing regimen. Plenvu was also tested as a 1-day morning only split-dosing regimen.
The study met both of its primary endpoints: Overall colon cleansing: when administered using a morning split dosing regimen, Plenvu is superior to MOVIPREP in achieving successful overall bowel cleansing success (97.3% vs. 92.2%,P=0.014, per protocol population). Right colon cleansing: Plenvu administered as either evening morning split dosing or morning only split dosing is superior to MOVIPREP (32.3% and 34.4% vs. 15.9% , P<0.001 for both, per protocol population).
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