A Study comparing effect of Generic Diclofenac Sodium Topical gel, 1% to Volteran Gel (Diclofenac sodium topical gel) 1 % in the treatment of subjects with Osteoarthritis of the knee

Dr. Kunal Bhalla; Dr. Pandab Chandra Paul

Volume : VI, Issue : I, January - 2017

A Study comparing effect of Generic Diclofenac Sodium Topical gel, 1% to Volteran Gel (Diclofenac sodium topical gel) 1 % in the treatment of subjects with Osteoarthritis of the knee

Dr. Kunal Bhalla, Dr. Pandab Chandra Paul

Abstract :

Background: Osteoarthritis (OA) is a highly prevalent chronic joint disease characterized by cartilage loss, synovial inflammation and bone remodeling. Occurring most frequently in the knee, the prevalence of OA in this joint increases with age. International guidelines for osteoarthritis care recommend considering use of topical NSAIDs as an alternative to oral NSAIDS. Objectives: The current study was designed to determine the therapeutic equivalence and safety of a topical application of generic Diclofenac sodium gel, 1% (Test Product) compared to Voltaren (Diclofenac sodium topical gel), 1% (Reference Product) in subjects with osteoarthritis of the knee. Material and Methods: Patients undergoing treatment for primary osteoarthritis of the knee, on O.P.D. basis were included in this study. The study followed a double – blind, randomized, vehicle controlled, parallel group design. Subjects meeting all entry criteria were randomly assigned to one of the three treatment groups in a 1:1:1 ratio. Results: There was a significant improvement in WOMAC pain score over 3 visits (0,2,4 weeks). 1% diclofenac gel showed comparable results against Volteran gel. Drug was relatively safe with no reported AEs or SAEs in either arm. Conclusion: Diclofenac sodium topical gel combines low systemic toxicity exposure to diclofenac with effective analgesia and potential tolerability benefits for adult patients with OA pain regardless of age.