Results of Double-Blind Comparative Trial of TS-110 on Post-extraction Pain Using Mefenamic Acid as Control Drug.
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To objectively evaluate the clinical usefulness of TS-110 (hereinafter veferred to as " T ") against the pain caused after extraction of the lower mandibular impacted wisdom tooth, a double-blind between-group comparison trial was conducted using mefenamic acid (hereinafter veferred to as " M ") as the control drug.<BR>1. Except for 40 of the 270 cases, 111 patients in the T group and 113 in the M group were analyzed for efficacy, 114 and 115 respectively were analyzed for safety and 111 and 112 for usefulness of the drug.<BR>2. Though there was no significant difference in the cumulative rate of no pain (imme-diacy) between the two groups, the rate was higher in the T group than in the M group up to 5 hours after extraction.<BR>3. There was no significant difference in the time up to the pain recurrence (persistence) . Those who did not feel recurring pain for more than 5 hours accounted for 75.3% (64/85) in the T group and 68.4% (54/79) in the M group.<BR>4. As for the overall pain improvement, those demonstrating "moderate improvement" or "marked improvement" acccounted for 78.4% (87/111) and 69.9% (79/113) in the respective groups, indicating that the improvement in the T group was more than or equal to that in the M group.<BR>5. Adverse effects occurred in 3 cases (2.6%) in the T group in the form of mild chill (2), headache (1) and chest pain (1), and in 2 cases (1.7%) in the M group in the form of moderate gastric discomfort (1), nausea (1), and mild stomachache (1) . None of these symptoms caused any clinical problem.<BR>6. As for usefulness, the drug was assessed as "safe" in 97.4% (111/114) of the T group and 98.3% (113/115) of the M group.<BR>7. As for usefulness, the drug was assessed as "useful" or "extremely useful" in 79.3% (88/111) of the T group and 78.6% (88/112) of the M group.<BR>As described above, TS-110 is a useful drug which has excellent quick and persistent action against post-extraction pain and which demonstrates analgesic effect more than or equal to that of mefenamic acid.
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