In order to find out the optimal dose of CN-100 in the field of dentistry, patients undergoing the extraction of the impacted mandibular wisdom tooth were subjected to a single-dose double blind comparative study of 80 mg and 160 mg. The results are hereafter reported.
1) The test drug was distributed to 173 patients, of whom 146 took the drug (72 cases in the 80 mg group and 74 in the 160 mg group) . Data from 143 cases (69 in the 80 mg group, 74 in the 160 mg group) were availed and subjected to the analysis for efficacy as well as the utility. Furthermore, the subjects for safety analysis in these cases have all taken the drug.
2) The attending doctors evaluated 49 cases (71.0 %) as “effective” or better in the 80 mg group and 69 cases (93.2 %) in the 160 mg group.
3) Adverse effects were observed in 3 cases in the 80 mg group. The symptoms included, “retching in the stomach”, “diarrhea” and “vertigo-postural syncope”. The global safety was rated as “safe” in 69 cases (95.8 %) in the 80 mg group and 74 cases (100 %) in the 160 mg group.
4) The utility was rated as “useful” or better in 50 cases (72.5 %) in the 80 mg group and 69 cases (93.2 %) in the 160 mg group.
5) In the Committee's evaluation, the global efficacy was rated as “effective” or better for 60 cases (87.0 %) in the 80 mg group and 72 cases (97.3 %) in the 160 mg group, and the utility was rated as “useful” or better in 69 cases (84.1 %) in the 80 mg group and 74 cases (97.3%) in the 160 mg group.
From the above results, a single dose of 160 mg is considered to be a rational dose of this drug in the treatment of pain after dental extraction. Furthermore, from the results of this study, it has been confirmed that, as an analgesic for the treatment of pain after dental extraction, this is a drug with excellent analgesic effect and safety.
View full abstract