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Nuvo Pharmaceuticals announced their European Ankle Sprain Study with Pennsaid 2 percent trial met its desired end goal.
Nuvo Pharmaceuticals (TSX:NRI) announced their European Ankle Sprain Study with Pennsaid 2 percent trial met its desired end goal.
As quoted in the press release:
The Trial
The Trial was conducted in Germany and enrolled 134 patients (the full analysis set or FAS) of which 122 patients followed the protocol (the per protocol set or PP) who had suffered a grade I or grade II ankle sprain as assessed by the investigator within 12 hours of injury. Patients were randomly assigned on a double-blind basis to an active arm or a control arm and applied either Pennsaid 2% or a control consisting of a topical vehicle that includes all the constituent ingredients of Pennsaid 2%, except its active ingredient diclofenac sodium (the Control) to their injured ankle twice a day for 8 days. The patients returned to the investigational site for in-depth evaluation on days 3, 5 and 8 of treatment. The primary endpoint for the Trial was reduction in pain on movement (POM) at day 3. The Trial also measured a number of secondary endpoints including ankle function, meaningful improvement in pain on movement, overall assessment of benefit and satisfaction, tenderness and ankle swelling. Patients also filled out a daily diary that recorded their answers to a number of standardized questions related to the negative impact of the injury on sleep and daily activities. The Trial commenced in November 2016 and was fully enrolled in March 2017.
Primary Endpoint
The primary endpoint for the Trial was reduction in pain on movement (POM) at day 3 in the FAS group. On average, patients treated with Pennsaid 2% had a larger reduction in POM scores over the course of the study. For the FAS group, the difference vs. Control was not statistically significant at the primary time point at day 3 (p=0.5074) or the secondary time point at day 5 (p=0.1642); however, was statistically significant at the secondary time point at day 8 (p=0.0099). In the PP group, the Pennsaid 2% group did not show a statistically significant improvement at day 3 (p=0.6996) or day 5 (p=0.1865), but did show a statistically significant improvement at day 8 (p=0.0154).
Click here to read the full press release.
Source: www.newswire.ca
