18+ Years
This is a 2-stage, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Dose and Treatment Effect of Subcutaneous Injection Pentosan Polysulfate Sodium Compared with Placebo in Adult Participants with Knee Osteoarthritis Pain. The study duration will be up to 31 weeks, treatment duration will be 6 weeks, visit frequency will be twice weekly during treatment and visit frequency will be every 4 weeks during the follow-up period.
Participants must be 18 years of age or older, with a clinical diagnosis of osteoarthritis of the knee, suffering moderate to severe knee pain, who were unresponsive to conservative therapy within the last 6 months and willing to stop treatment with all other systemic pain medications for the duration of the trial.
A. ≥ 12yo to <18, weight > 40kg (adolescent group)
B. ≥ 18yo (adult group)