Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%

Exclusion Criteria

• •1. Females who are pregnant, breast feeding, or planning a pregnancy
• •2. Radiograph of the target knee within the previous year with a Grade 4 score on the Kellgren-Lawrence disease severity scale. 24
• •3. History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
• •4. After a 7 day wash out of all pain medication has baseline pain on movement score of ≥ 20mm on a 100-mm Visual Analogue Scale for the contralateral knee immediately prior to randomization.
• •5. Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) or rheumatoid arthritis.
• •6. Known history of other chronic inflammatory diseases, (e.g.,colitis) or fibromyalgia.
• •7. History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
• •8. History of coronary artery bypass graft within 6 months of screening.
• •9. Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max 162mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
• •10. Use of warfarin or other anticoagulant therapy within 30 days of screening.
• •11. Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of screening or during the study.
• •12. Known history of gastrointestinal bleeding or peptic ulcer disease.
• •13. Abnormal screening clinical laboratory evaluations which the Investigator determines are clinically significant.
• •14. Known allergy to aspirin or NSAIDs.
• •15. Results from liver function tests that are more than two times the upper limit of the normal range at screening.
• •16. Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the Patient at risk by participating in the study.
• •17. Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization.
• •18. Receipt of any drug as part of a research study within 30 days prior to screening.
• •19. Previous participation in this study.