Nuvo Pharmaceuticals™ Inc. Announces Pennsaid 2% Phase 3 Trial to Support Regulatory Approvals in the E. U., Canada and Australia
"The Trial incorporates what we learned from a similar trial that we conducted in 2015 that produced encouraging results and we believe that Pennsaid 2% can show positive results in this setting," said John London, Nuvo's President and CEO. "In particular, we have changed the primary endpoint (pain on movement) to the third day after initial treatment which was a secondary endpoint at which Pennsaid 2% demonstrated statistical significance in the 2015 trial."
The Trial will be conducted in Germany and will enroll approximately 130 patients who have suffered a grade I or grade II ankle sprain as assessed by the investigator within 12 hours of injury. Patients will then be randomly assigned on a double-blind basis to an active arm or a placebo arm and will apply either Pennsaid 2% or a placebo consisting of a topical vehicle that includes all of the constituent ingredients of Pennsaid 2%, except its active ingredient diclofenac sodium, to their injured ankle twice a day for 8 days. The patients will return to the investigational site for in-depth evaluation on days 3, 5 and 8 of treatment. The primary endpoint for the Trial will be reduction in pain on movement (POM) at day 3. The Trial will measure a number of secondary endpoints including tenderness, ankle function, ankle swelling, overall assessment of benefit and satisfaction and use of rescue medication.
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