This study was designed to evaluate the effectiveness in relief of pain and rigidity of a 10|X% trolamine salicylate cream compared with a placebo cream identical in smell and appearance, for subjects with osteoarthritis in their hands. This was a one-application, randomized, double-blind, placebo-controlled, parallel study conducted in 81 patients. Pain and stiffness were assessed in the morning upon subjects' awakening (baseline) and at 30, 45, and 120 min after a 4-min rubbing application. Analgesic response was determined using the sum of pain intensity differences (SPID) and the sum of stiffness intensity differences (SSID); the sum across the observation points derived from a pain/stiffness rating scale. Trolamine salicylate was significantly superior to the placebo in improving SPID (p = 0.0492) and in improving SSID scores for both hands (p = 0.0283). Treatment differences in absolute pain and stiffness scores were significant (p |Ml 0.05) at 45 min after application. A 10|X% trolamine salicylate cream was shown to be safe and effective for the temporary relief of minor pain and stiffness associated with osteoarthritis in the hands. This formulation has no smell or counter-irritating properties; patient acceptability was good.