A single dose of TS-110 of 4, 6, and 8 mg was administered to the lower mandibula because of impacted wisdom tooth post-extraction pain, and the clinical usefulness and optimum dose were investigated by the double-blind method.
1. For assessment of overall improvement of pain and analysis of usefulness, there were 86, 91, and 84 patients in the 4, 6, and 8 mg groups respectively, and for analysis of general safety, there were 86, 92, and 85 patients in the respective groups.
2. Significant differences among these three groups were observed in the cumulative analgesia rate based on a duration method, and the time to become pain-free tended to be much shorter with 8 mg than with 4 mg.
3. Significant differences among these three groups were observed with respect to patient impressions, but significant differences between two groups were not observed.
4. Significant differences among these three groups were observed in overall improvement of pain, and the 8 mg was significantly better than 6 mg. In addition, the percent of patients with moderate improvement or greater was 81.4%, 73.6%, and 85.7% in the 4, 6 and 8 mg groups respectively, and a significant difference was not observed, but the percentages of marked improvement were 39.5%, 37.4%, and 56.0% respectively, and the 8 mg group was significantly better than the 6 mg group.
5. There were only two cases (2.2%) of adverse reaction in the 6 mg group ; mild gastric pain and diarrhea.
6. Significant differences among these three groups in regard to usefulness were not observed. As a result the optimum dose of TS-110 for post-extraction pain was considered to be a single dose of 8mg.
