A Randomized, Double-blind, Phase III Trial in Moderate Osteoarthritis Knee Pain Comparing Topical Ketoprofen Gel with Ketoprofen-free Gel

Abstract

This randomized, double-blind, phase III study evaluated the efficacy and safety of ketoprofen in an ultradeformable vesicle gel compared with ketoprofen-free gel in osteoarthritis (OA) knee pain. Patients with American College of Rheumatology-defined OA of the knee and moderate pain were randomized to receive 100 mg ketoprofen in 4.4 g transfersome gel (IDEA-033) or 4.4 g ketoprofen-free vehicle (TDT 064) topically, twice daily, for 12 weeks. The primary endpoint was mean change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score from baseline to Week 12. Patients (n = 555) were randomized and treated. Mean baseline WOMAC pain scores were 5.2 (SD 1.0) for IDEA-033 and 5.3 (SD 1.0) for TDT 064. Mean change in WOMAC pain scores from baseline to Week 12 was 38.6% for IDEA-033 and 44.6% for TDT 064 (Mann-Whitney estimator 0.4505; p = 0.022). Both groups reported progressive decreases in pain and improvements in function and stiffness. Mean baseline WOMAC function scores decreased from 5.4 to 3.4 with IDEA-033 and 3.1 with TDT 064 at Week 12. The proportion of patients achieving ≥ 50% decrease in WOMAC pain score from baseline at Week 12 was 41.2% (95% CI 0.35-0.47) with IDEA-033 and 50.5% (95% CI 0.45-0.57) with TDT 064. Mild skin and subcutaneous tissue disorders were the most frequently reported treatment-related adverse events (AE). IDEA-033 was inferior to drug-free gel (TDT 064) in relieving moderate OA knee pain and improving joint function.