A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"
Status:
Completed
Trial end date:
2017-12-05
Target enrollment:
Participant gender:
Summary
This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with
clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's
diclofenac gel in the symptomatic treatment of osteoarthritis of knee compared to Voltaren®
gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.
Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of
the knee according to the American College of Rheumatology (ACR) criteria
Total study duration for the clinical part will be around 56 days that includes screening
period of 28 days and treatment period of 4 weeks.