Efficacy and Safety of Etodolac-Paracetamol Fixed Dose Combination in Patients With Knee Osteoarthritis Flare-up: A Randomized, Double-blind Comparative Evaluation

OBJECTIVETo evaluate the efficacy and safety of etodolac-paracetamol combination in comparison with etodolac alone in patients with knee osteoarthritis (OA) flare-up. METHODSIn this double-blind, double-dummy, randomized, comparative, multicentric, parallel group study, 220 patients of either sex in the age range of 40 to 70 years with an OA flare-up were randomized either to etodolac (300 mg)-paracetamol (500 mg) combination or etodolac (300 mg) alone twice a day for 10 days. Efficacy outcomes were an average daily pain intensity score on 11-point visual analog scale, Western Ontario and McMaster score (WOMAC), and Lequesne Severity Index; total pain relief score at 30 minutes, 1, 2, and 4 hours after first-dose administration; OA flare-up symptoms resolution; patientʼs and investigatorʼs overall assessment of study treatments. RESULTSEtodolac-paracetamol was significantly superior to etodolac alone in reducing pain intensity (P