Topical diclofenac patch in patients with knee osteoarthritis: a randomized, double-blind, controlled clinical trial.
OBJECTIVE
To assess the efficacy and safety of a diclofenac hydroxyethylpyrrolidine (DHEP) patch in the treatment of symptomatic osteoarthritis (OA) of the knee joint.


METHODS
A double-blind, randomised, placebo-controlled trial was carried out on 103 outpatients for 2 weeks. The main efficacy parameters were spontaneous pain and Lequesne's Index. Secondary endpoints were walking time over a standard distance, global assessment of efficacy and tolerability, and paracetamol consumption.


RESULTS
The active treatment group showed a significant improvement in pain, Lequesne's Index, and the physician's and patient's global assessment of efficacy. For these parameters the difference between groups was statistically significant in favour of the DHEP patch. Adverse reactions were seen in a small number of probands and were similar in both groups.


CONCLUSIONS
The results of this trial suggest that the DHEP patch appears to be an effective and safe treatment for patients suffering from symptomatic knee OA.
Department of Rheumatology and Physical Medicine, University Hospital Zurich, Switzerland.
P
P
Brühlmann
B A
BA
Michel
D000279:Administration, Cutaneous; D000368:Aged; D018771:Arthralgia / Q000188:drug therapy / Q000209:etiology; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage*; D004008:Diclofenac / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
D016861:Cyclooxygenase Inhibitors; C064142:diclofenac hydroxyethylpyrrolidine; D004008:Diclofenac