The efficacy and safety of aceclofenac 1.5% cream and piroxicam 1% cream in 220 patients with soft-tissue injuries were evaluated in a double-blind, randomized, multicenter, comparative, parallel-group trial. Patients were randomly assigned to each treatment group to receive therapy three times a day for 7 days. The primary outcome measure of pain was evaluated using a visual analog scale (VAS) at baseline, day 4, and day 7 of the study. Safety was assessed by recording any adverse events that occurred and by monitoring any hemato-biochemical alterations during the study. After days 4 and 7 of treatment, a significant improvement (P <0.05) was observed for both groups with respect to baseline conditions for all efficacy variables evaluated. The statistical analysis showed no significant differences between treatments for all parameters except for subjective pain, which favored the piroxicam group (P <0.05). Both topical formulations were well tolerated: Only local adverse events of mild intensity were reported by three patients treated with aceclofenac. The overall assessment of tolerability was reported by physicians and patients as being either good or very good in both groups. The results of this study confirm that aceclofenac cream is effective in relieving pain, improving functional capacity, and reducing swelling related to acute injuries of soft tissues.
ASJC Scopus subject areas
- Pharmacology (medical)