1990 Volume 36 Issue 10 Pages 2403-2414
Clinical usefulness of N-22 (Mofezolac; N), a new non-steroidal antiinflammatory agent, on post-exodontic pain was evaluated at a single dose level of 150mg/time, in a double-blind comparative study, in comparison with Mefenamic acid; M also at a single dose level of 500 mg/time; results are summarized as follows.
Of a total of 228 cases, 33 with no onset of post-exodontic pain took neither of the agents and were therefore removed, meaning that 195 cases were subjected for analysis, in comparison with M put under previously well controlled studies. No significant difference in patient background factors between N and M groups was found. Based on the protocol, either N or M was administered alone for evaluation at a single dose level/time. Double dummy method was used in allotment for administration of 4 kinds of test agents-N, NI, N's placebo and M's placebo.
Of a total of 193 efficacy evaluable cases (N-96 & M-97), 25.0% of N group and 11.3% of M were rated “Remarkably improved” in final global improvement rate, with N group found significantly superior (P<0.05). Of a total of 194 safety evaluable cases, such adverse reactions as headache/nausea and drowsiness each in one case of N (2 in all); drowsiness/irritability, diarrhea, abdominal pain and drowsiness/languor each in one case of M (4 in all) occurred, none of which was found clinically serious, with no significant difference between the two groups.
From the foregoing study, N-22 is found clinically useful, with little difference between a single dose of N 150 mg and that of M 500mg.