A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Diclofenac sodium gel 1%; Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%; Placebo gel
Intervention description: 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
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1220.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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).