Efficacy and safety of epicutaneous ketoprofen in Transfersome (IDEA-033) versus oral celecoxib and placebo in osteoarthritis of the knee: multicentre randomised controlled trial.
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
This was a 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 6 weeks. Primary efficacy outcome measures were the changes from baseline to end of the study on the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index 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, respectively, and 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), respectively. 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), respectively. The differences in change between IDEA-033 and placebo were statistically significant for pain subscale (p<0.01) and PGA of response (p<0.01). Gastrointestinal adverse events for IDEA-033 were similar to placebo.


CONCLUSIONS
IDEA-033 is superior to placebo and comparable with celecoxib in relieving pain associated with an acute flare of knee osteoarthritis.
Rother
Matthias
M
IDEA AG, Frankfurter Ring 193a, 80807 Muenchen, Germany. rother@idea-ag.de
Lavins
Bernard J
BJ
Kneer
Werner
W
Lehnhardt
Klaus
K
Seidel
Egbert J
EJ
Mazgareanu
Stefan
S
D000279:Administration, Cutaneous; D000284:Administration, Oral; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000627:therapeutic use; D000068579:Celecoxib; D004185:Disability Evaluation; D004311:Double-Blind Method; D004337:Drug Carriers; D005260:Female; D006801:Humans; D007660:Ketoprofen / Q000008:administration & dosage* / Q000627:therapeutic use; D016018:Least-Squares Analysis; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D011720:Pyrazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D012869:Skin Absorption; D013449:Sulfonamides / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004337:Drug Carriers; D011720:Pyrazoles; D013449:Sulfonamides; D007660:Ketoprofen; D000068579:Celecoxib