Objective: To compare epicutaneous ketoprofen in Transfersome® (ultra-deformable vesicles, IDEA-033) versus oral celecoxib and placebo for relief of signs and symptoms in knee osteoarthritis.
Methods: Multicentre, randomised, double blind, controlled trial; 397 patients with knee osteoarthritis participated and 324 completed the trial. They were randomly assigned 110 mg epicutaneous ketoprofen in 4.8 g Transfersome® plus oral placebo (n =138), 100 mg oral celecoxib plus placebo gel (n = 132), or both placebo formulations (n = 127) twice daily for six weeks. Primary efficacy outcome measures were the changes from baseline to end of study in Western Ontario and McMaster Universities (WOMAC) Index of Osteoarthritis pain subscale, physical function subscale, and patient global assessment (PGA) of response.
Results: The mean WOMAC pain subscale scores in the intent to treat population were reduced by 18.2 (95% confidence interval -22.1 to -14.3), 20.3 (-24.3 to - 16.2), and 9.9 ( 13.9 to -5.8) in the IDEA-033, celecoxib, and placebo groups; the physical function subscale score by 14.6 (-18.1 to -11.0), 16.6 (-20.2 to - 13.0), and 10.2 (-13.8 to -6.6). The mean PGA of response scores were 1.8 (1.6 to 2.1), 1.7 (1.5 to 1.9), and 1.3 (1.1 to 1.5). The differences in change between IDEA-033 and placebo were statistically significant for pain subscale (p=0.0041) and PGA of response (p=0.0015). Gastrointestinal adverse events for IDEA-033 were similar to placebo.
Conclusion: IDEA-033 is superior to placebo and comparable with celecoxib in relieving pain associated with an acute flare of knee osteoarthritis.
- clinical trial