Pain Associated With Osteoarthritis of the Knee Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind, 22-Week and 30-Week Open-label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of X0002 Spray in Relief of the Pain for Subjects With Osteoarthritis of the Knee
This is a Phase 3, Multicenter, 22-Week, double-blind and 30-Week open label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of pain of subjects with Osteoarthritis of the Knee.
The study comprises a 14-day Screening Period, a 22-week Double-blind Treatment Period, and a 30-week Open-label Treatment Period, with an additional 4-week Follow-up Visit. Subjects will be randomized into a low-dose or high-dose group receiving either active or placebo treatment during the DB period. The WOMAC version 3.1 using the NRS will be used for the primary and secondary efficacy endpoints. Safety assessments will include assessment of AEs, vital signs (blood pressure, respiratory rate, pulse rate, and oral temperature), clinical laboratory tests, physical examination, skin irritation, and electrocardiograms (ECGs). ;