Results of Dose Finding Study on TS-110 for Post-extraction Pain.
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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.<BR>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.<BR>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.<BR>3. Significant differences among these three groups were observed with respect to patient impressions, but significant differences between two groups were not observed.<BR>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.<BR>5. There were only two cases (2.2%) of adverse reaction in the 6 mg group ; mild gastric pain and diarrhea.<BR>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.
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