A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"

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

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.

Inclusion Criteria:

• Osteoarthritis knee as per American College of Rheumatology (ACR) criteria
• Evidence of OA with Kellgren-Lawrence grade 1-3 disease.
• After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
• After discontinuing all pain medications for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of ≥ 9 immediately prior to randomization.
• Able to tolerate rescue medication with acetaminophen
• Subjects who can read and understand WOMAC pain sub scale

Exclusion Criteria:

• Pregnancy, lactation
• OA of Kellgren-Lawrence grade 4
• OA pain in the contralateral knee requiring medication (OTC or prescription)
• History of OA of either Hip or Hands
• History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
• History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
• History of Drugs or Alcohol abuse within the previous year
• Symptomatic peripheral vascular disease of the study leg
• Any musculoskeletal condition
• Skin disease at the application site
• Active asthma requiring periodic treatment with systemic steroids
• Known history of positive HIV, hepatitis C virus, or HBsAg
• Uncontrolled hypertension
• History of myocardial infarction, thrombotic events, stroke etc.
• Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).