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.
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.
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.
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.
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.
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.
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.
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.
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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