BioCentury
ARTICLE | Clinical News

MuGard: Phase IV data

March 3, 2014 8:00 AM UTC

Data from 78 evaluable head and neck cancer patients receiving chemoradiation therapy in a double-blind, U.S. Phase IV trial showed that oral MuGard significantly reduced area under the curve of daily patient-reported OMDQ scores, the primary endpoint, from baseline to last day of chemoradiation therapy vs. sham control (p=0.034). Additionally, MuGard significantly reduced World Health Organization (WHO) OM scores from baseline on the last day of chemoradiation therapy vs. sham control (p=0.038). MuGuard also non-significantly reduced opioid use duration and WHO OM scores at week 4 of chemoradiation therapy. No significant adverse events were reported. The trial enrolled 120 patients to receive 5 mL aqueous control rinse or 5 mL MuGard rinse every 3 hours while awake for up to 6 times daily. Data were published in Cancer. In 2012, Access reported interim data from 40 patients in the trial (see BioCentury, April 30, 2012). ...