Clinical evaluation of CN-100 for the relief of pain after tooth extraction

—A multi-institutional Cooparative double blind comparative study using mefenamic acid as the control drug—

Abstract

To evaluate the analgesic effect of CN-100, a new nonsteroidal anti-inflammatory agent, we conducted a double blind clinical study comparing the efficacy of CN-100 (CN) with that of mefenamic acid (MA) on pain after the extraction of impacted wisdom tooth of the mandible and the following results were obtained:
1) There were 140 participants, with 139 cases included in the evaluation of effectiveness and usefulness, consisting of 65 cases in the CN group and 74 cases in the MA group. In the safety evaluation, 70 cases in the CN group and 79 cases in the MA group were included.
2) The rats of “Excellent” efficacy and “Good” or better efficacy as shown by patients' impressions and investigators' judgment were slightly higher in the CN group than in the MA group, and no significant difference was observed between the two groups.
3) The efficacy rates on the evaluation items shown according to the Criteria of the Committee in the CN group were equivalent or slightly superior to those in the MA group, and no statistically significant difference was observed between the two groups.
4) No adverse reaction was observed in either group.
5) In total, the results suggested that CN-100 has an excellent analgesic effect for pain relief after tooth extraction and is highly safe, and therefore CN-100 has been considered to be a useful agent.