Estimates of Doses of Antiinflammatory Drugs in Man by Testing for Analgesic Potency

Abstract

Dosage estimates of antiinflammatory drugs in human arthritis Phase II trials are difficult to obtain and prolong such trials unnecessarily. Antiinflammatory drugs almost always have analgesic properties in man, and good dose estimates for analgesic activity can be obtained. In 140 patients with surgical pain, 300, 600 and 1200 mg of aspirin were compared to 75, 150 and 300 mg of 43-715 (1-isopropyl-4 phenyl-7-methyl-2 (1H) quinazolone), an antiinflammatory quinazolone derivative, for analgesia in a double-blind trial using subjective response methodology. The test drug was shown to be analgesic at a level 4 times more potent, milligram for milligram, than aspirin, an estimate that should be useful for later definitive Phase II trials in arthritis.