Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Diclofenac Sodium Topical Gel, 1%; Voltaren Topical Gel, 1%; Vehicle Diclofenac Sodium Topical Gel
Intervention description: Opaque, white gel; Opaque, white gel; Opaque, white gel
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1176.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Knee

Summary:

      To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical
      Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a
             clinical diagnosis of OA of the knee.

          -  Had an X-ray of the target knee, taken no more than 1 year before baseline, showing
             evidence of OA with Kellgren-Lawrence grade 1-3 disease.

          -  After discontinuing all pain medications for at least 7 days, has at least moderate
             pain on movement for target knee

          -  If female and of child-bearing potential, agree to abstain from sexual intercourse or
             use a reliable method of contraception during the study

          -  Able to tolerate rescue medication with paracetamol/acetaminophen.

        Exclusion Criteria:

          -  Pregnant or lactating or planning to become pregnant during the study period.

          -  X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.

          -  History of OA pain in the contralateral knee requiring medication within 1 year prior
             to screening.

          -  After discontinuing all pain medications for at least 7 days, has a baseline score of
             ≥20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately
             prior to randomization.

          -  History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or
             fibromyalgia.

          -  History of asthma, hypertension, myocardial infarction, thrombotic events, stroke,
             congestive heart failure, impaired renal function or liver disease.

          -  History of gastrointestinal bleeding or peptic ulcer disease.

          -  Use of warfarin or other anticoagulant therapy within 30 days of study randomization.

          -  Elevated transaminases at screening.

          -  Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30
             days of study randomization.

          -  Concomitant use of corticosteroids or use within 30 days of study randomization.

          -  Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac
             prophylaxis taken for at least 3 months prior to enrollment and maintained throughout
             the duration of the study.

          -  Known allergy to aspirin or nonsteroidal anti-inflammatory drug

          -  Any other acute or chronic illness that could compromise the integrity of study data
             or place the subject at risk by participating in the study.

          -  Receipt of any drug as part of a research study within 30 days prior to screening.

          -  Previous participation in this study.

          -  Any use between screening and baseline of a treatment or medication that may
             potentially confound study assessment that may potentially confound study assessment
             (e.g. use of topical analgesics or anti-inflammatory drugs).

          -  Recent history of major knee injury or surgery.

          -  Known history of positive HIV