Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: PENNSAID Gel; Vehicle
Intervention description: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks; 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
Intervention MeSH terms: Diclofenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Arthritis; NSAIDs; Topical NSAID; Diclofenac; PENNSAID

Summary:

      Osteoarthritis (OA) is the most common form of arthritis. It can cause pain, swelling, and
      reduced motion in the joints. That can reduce quality of life.

      OA can occur in any joint, but usually affects the hands, knees, hips or spine.

      The purpose of this study is to find out if doctors might be able to use 2% PENNSAID gel to
      treat OA in the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Primary osteoarthritis of the knee

          2. Radiologic evidence of OA of the knee

          3. On stable pain therapy with an oral or topical NSAID or acetaminophen

          4. Experience a "moderate flare" of pain following washout of stable pain therapy

          5. Able to read and understand English or Spanish to answer pain assessment questions
             without any explanation

          6. If female, surgically sterile or non-pregnant

          7. Except for OA, in reasonably good general health

          8. Written informed consent

        Exclusion Criteria:

          1. Secondary OA of the study knee

          2. History of pseudo gout or inflammatory flare-ups

          3. Participation would conflict with contraindications, warnings or precautions as stated
             in the prescribing information for oral or topical diclofenac

          4. Severe, uncontrolled cardiac, renal, hepatic, or other systemic disease

          5. Any malignancy within the previous 3 years, except local therapy for superficial skin
             cancer not on the study knee

          6. Known sensitivity to the use of oral or topical diclofenac, aspirin [acetylsalicylic
             acid (ASA)] or any other NSAID, dimethyl sulfoxide (DMSO), or ethanol

          7. Ongoing abnormality that could confound interpretation of the safety results (eg,
             anemia, unresponsive gastrointestinal [GI] reflux, etc.)

          8. Documented gastroduodenal ulcer or any GI bleeding (except hemorrhoidal) within the
             last 6 months

          9. Uncontrolled diabetes

         10. Screening laboratory test results of serum creatinine ≥ 1.5 times upper limit of
             normal; aspartate aminotransferase (AST), alanine aminotransferase (ALT), or
             gamma-glutamyltransferase (GGT) ≥ 3 times upper limit of normal; and hemoglobin less
             than or equal to lower limit of normal

         11. Documented alcohol or drug abuse within 1 year

         12. If female, breast-feeding

         13. Major surgery or previous damage to the study knee at any time, or minor knee surgery
             to the study knee within 1 year

         14. Requires oral or intra-muscular corticosteroids, or received an intra articular
             corticosteroid injection into the study knee within the past 90 days, or into any
             other joint within the past 30 days, or currently applying topical corticosteroids
             onto the study knee

         15. Received intra-articular viscosupplementation (eg, hylan G-F 20 [Synvisc®]) in the
             study knee in the past 6 months

         16. On prior stable therapy (ie, more than 3 days per week for the previous month) with an
             opioid analgesic prior to the screening visit will be excluded.

         17. Recently started taking a sedative hypnotic medication for insomnia

         18. Taking anti-depressants

         19. Not willing to discontinue prohibited medications/therapies

         20. Cannot tolerate acetaminophen

         21. Re-entering study after dropping out or withdrawn from study

         22. Used another investigational drug within the previous 30 days

         23. On or currently applying for disability benefits on the basis of knee OA

         24. History of fibromyalgia

         25. Other painful or disabling conditions affecting the knee or leg, or disabling
             condition of the hands (used to apply the study drug)

         26. Skin disorder with current involvement on the hands (used to apply the study drug) or
             the knee(s) (application site)

         27. Referred to an orthopedic surgeon for consideration of, or been advised to have, knee
             replacement or knee reconstruction surgery

         28. Radiologic evidence of OA of the knee advanced to the point that all cartilage has
             been eroded (ie, bone on bone)

         29. Recently started using a cane within the past 30 days

         30. History of chronic headaches that may require more than occasional use of rescue
             medication for headaches