Objective: To evaluate efficacy and safety of aceclofenac-paracetamol combination against aceclofenac alone in patients with osteoarthritis (OA) flare-up.
Methods: This open, randomized, comparative, multicentric, 10-day study enrolled 199 patients (aceclofenac 100 mg + paracetamol 500 mg bid: 101; aceclofenac 100 mg, bid: 98) with painful OA flare-up. Primary efficacy parameters were pain intensity difference (PID), sum of PID (SPID), and peak PID over 4 h (0.5, 1, 2, 4 h) after first dose of study medication. Secondary efficacy measurements were mean pain intensity scores from day 1 to day 10, WOMAC scores, changes in baseline signs and symptoms, and patient's and investigator's overall efficacy assessment.
Results: Both treatments showed significant improvement in their baseline values in all efficacy parameters. The combination was superior over monotherapy in terms of PID ( -0.54 vs -0.23, -1.23 vs -0.72, -1.73 vs -1.23 and -1.94 vs -1.43 at 0.5, 1, 2 and 4 h respectively), SPID ( -5.46 vs -3.63) and peak PID ( -2.08 vs -1.56; p < 0.05). At the end of therapy, both treatments were comparable (p > 0.05) with respect to average pain intensity from day 1 to day 10, changes in WOMAC scores and resolution of baseline signs and symptoms. The combination was significantly superior to monotherapy with respect to the patients' and investigators' overall efficacy assessments (p = 0.035 and p = 0.009 respectively).
Conclusion: The findings of this open-label, comparative study in Indian patients demonstrates that aceclofenac-paracetamol combination is effective and well tolerated in relieving OA flare-up pain. The combination showed rapid pain relief compared with monotherapy which is desirable by such patients and, hence, this combination can play an important role in the management of acute painful OA flare-up.