A single-dose study of the efficacy and safety of FS 205-397 (250 mg or 500 mg) versus aspirin and placebo in the treatment of postsurgery dental pain.
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| Abstract |
The efficacy and safety of two dose levels of FS 205-397 (either 250 or 500 mg) were compared with the efficacy and safety of aspirin 650 mg and placebo in a 6-hour, single-dose, double-blind study in 161 patients who had undergone extraction of third molars. Each of the doses of FS 205-397, as well as aspirin, produced analgesia. However, the analgesic effects of both the 500 mg dose of FS 205-397 and aspirin were at times significantly better and more prolonged than those produced by the lower dose of FS 205-397. On the other hand, both doses of FS 205-397 had a significantly faster onset of action than aspirin. Side effects, reported by 17% of the 161 patients, did not differ significantly among the four treatment groups with respect to frequency, type, or severity. The most commonly reported side effects were nausea (7%) and drowsiness (6%). The results indicated that FS 205-397, administered in single doses of either 500 or 250 mg, is a safe and effective analgesic for the relief of pain following dental surgery, and may offer particular advantages in terms of onset of effects.
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| Authors | D R Mehlisch, W R Sterling, F A Mazza, J M Singer |
| Journal | Journal of clinical pharmacology (J Clin Pharmacol) Vol. 30 Issue 9 Pg. 815-23 (Sep 1990) ISSN: 0091-2700 [Print] England |
| PMID | 2277129 (Publication Type: Clinical Trial, Comparative Study, Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't) |
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