US-based pharmaceutical company Nuvo has announced its intention to conduct a Phase III trial of Pennsaid 2% in Germany to treat acute ankle sprains.
Pennsaid 2% is a topical, non-steroidal, anti-inflammatory drug (NSAID) composed of 2% diclofenac sodium.
It is a gel formulation applied in a metered dose pump bottle.
The trial is designed to support regulatory approvals in the European Union, Canada and Australia.
Nuvo president and CEO John London said: "The trial incorporates what we learned from a similar trial conducted in 2015 that produced encouraging results, and we believe Pennsaid 2% can show positive results in this setting.
"In particular, we have changed the primary endpoint (pain on movement) to the third day after initial treatment, which was a secondary endpoint whereby Pennsaid 2% demonstrated statistical significance in the 2015 trial."
The placebo-controlled, multi-centre trial plans to involve approximately 130 patients who are experiencing a grade I or grade II ankle sprain.
During the trial, the patients will be randomly assigned on a double-blind basis to an active arm or a placebo arm and will be administered to either Pennsaid 2% or a placebo, which consists of all the constituents of Pennsaid 2% except its active ingredient diclofenac sodium.
It will be applied on the patients' injured ankles twice a day for a duration of eight days.
The trial is primarily focused on achieving a reduction in pain of movement (POM) after three days, while the secondary endpoints are to reduce tenderness, ankle function, ankle swelling and achieve an overall clinical benefit of the medication.