Japanese Journal of Oral and Maxillofacial Surgery
Online ISSN : 2186-1579
Print ISSN : 0021-5163
ISSN-L : 0021-5163
A Double-Blind comparative study of N-22 (Mofezolac), a nonsteroidal anti-inflammatory agent, in pain after tooth extraction
Clinical evaluation by use of mefenamic acid the control
Shojiro TAKAHASHIChikara SAITONobuo TAKANONoboru SONOYAMAMinoru UCHIDAYasuo KUMAZAWAYasunobu UCHIDAYasukazu KUDOHidekuni OZEKIKenichi MICHIAtsushi NAKAMURAKatsunori ISHIBASHIEtsuo KIMORIHaruyasu TANABEMasahiro NAKAZAWAYoshio IWASAKI
Author information
JOURNALS FREE ACCESS

1990 Volume 36 Issue 10 Pages 2403-2414

Details
Abstract

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.

Information related to the author
© Japanese Society of Oral and Maxillofacial Surgeons
Previous article
feedback
Top