The efficacy and safety of a topical formulation of 2% diclofenac sodium in PHLOJEL® was assessed in a double-blind, randomized, placebo-controlled clinical trial on patients with mild to moderate osteoarthritis (OA) of the knee.
The WOMAC VA3.0 Osteoarthritis Index is a disease specific indicator for OA of the knee, and was used to assess clinical outcomes for 70 patients assigned either placebo or treatment gel during the course of a 2-week study period.
Results indicated a significant improvement (two-tailed, paired t-test, p=0.05) from baseline for the treatment group in 23 of 24 categories, whereas the placebo group showed significance for only 3 of 24 categories.
There was no significant difference between groups in the numbers of adverse event reports. The treatment group had 6 cases (4 rash, 1 nausea, 1 hirsutism) and the placebo group had 9 cases (5 rash, 2 nausea, 1 pruritis). All cases were mild in severity and did not require treatment.
“Topical Diclofenac versus Placebo. A Double-Blind, Randomized Clinical Trial in Patients with Osteoarthritis of the Knee”, D. W. Grace, J. A. Rogers, K. J. Skeith and K. E. Anderson. Journal of Rheumatology (1999) 26:2659-2663