The efficacy and safety of
aceclofenac control release (CR)
tablets was compared with conventional
aceclofenac tablets in patients with
knee osteoarthritis (OA). This was a double-blind, double-dummy, randomized, parallel group multicentric study conducted at 6 centers. Two hundred and eighty five patients were randomized to either
aceclofenac-CR (n = 143) once daily or conventional
aceclofenac tablet (n = 142) twice daily and were followed for 6 weeks. The efficacy parameters were
pain intensity score on visual analogue scale, Western Ontario and McMaster (WOMAC) score, patients and investigator's overall study
drug assessment and total consumption of
acetaminophen and
ranitidine tablets. Both treatments showed significant improvement in their efficacy parameters from baseline at the end of
therapy.
Aceclofenac-CR was comparable to conventional
aceclofenac with respect to change in
pain intensity and WOMAC score (P > .05) There was no statistically significant difference between the treatment groups in patient's and investigator's overall study
drug assessment at the end of
therapy (P > .05).
Aceclofenac-CR treated patients took fewer
acetaminophen and
ranitidine tablets during the treatment period as compared to conventional
aceclofenac treated patients. Both the study medications were well tolerated with no incidence of serious adverse event (SAE). In conclusion, the new
aceclofenac-CR formulation was found to be effective and safe while offering practical advantage of once daily administration.
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