At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind, Three-arm, Parallel, Placebocontrolled, Clinical Study to Evaluate the Bioequivalence Using Clinical Endpoint of Diclofenac Sodium Gel, 1% (Mylan Inc.) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc.) in Patients With Osteoarthritis (OA) of the Knee
In Brief
A Phase 3 clinical trial evaluating Diclofenac sodium gel 1%, Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%, and 1 other intervention for Osteoarthritis, Knee. Completed, enrolled 1,220 participants across 32 sites.
Detailed 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.
Study Details
Timeline
Interventions
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Vehicle Gel 4 gm, 4 times a day for 4 weeks