title: A comparative subjective assessment study of PENNSAID® and Voltaren Gel®, two topical formulations of diclofenac sodium.
abstract: Osteoarthritis (OA) is a chronic degenerative joint disease that is debilitating for many individuals. While oral nonsteroidal anti-inflammatory drugs (NSAIDs) remain a common and effective treatment approach to managing OA, concerns over cardiovascular and gastrointestinal adverse events can potentially limit their use. Various formulations of topical NSAIDs have been shown to provide effective localized treatment with minimal adverse events. A patient perception study was conducted to evaluate patient preference between topical diclofenac sodium gel and that of diclofenac sodium topical solution with the penetration enhancer dimethyl sulfoxide (DMSO). Twenty-four healthy volunteers were randomized and asked to administer one dose of the topical products. Surveys were provided and assessed immediately after application, 5 minutes after application, and after the application had dried to gauge subjects' overall experience with the topical preparation. Overall, each drug's application was well tolerated and no adverse events were reported. Results of the patient preference survey demonstrated that topical diclofenac solution with DMSO had a number of characteristics that were rated significantly better than for diclofenac sodium gel. Mean subjective responses to topical diclofenac solution with DMSO were also more favorable for most items in the questionnaire, and more subjects preferred or highly preferred topical diclofenac solution with DMSO over diclofenac sodium gel.
authors.affiliation: Nuvo Research Inc., West Chester, Pennsylvania 19382, USA. bgaler@nuvoresearch.com
authors.forename: Bradley S
authors.initials: BS
authors.lastname: Galer
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical; D004008:Diclofenac / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D012720:Severity of Illness Index; D016037:Single-Blind Method
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac