Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants

Exclusion Criteria

• •Unwilling to abstain from oral NSAIDs and/or other analgesic medication except for acetaminophen as rescue medication. Subjects taking low dose aspirin for cardiovascular health may remain on their stable dose throughout the study.
• •Unwilling to abstain from taking \< than or equal to 1500mg of acetaminophen a day for rescue medication purposes during the 6 week course of the trial.
• •Using a handicap assistance device i.e. cane, walker \> than or equal to 50% of the time.
• •Undergoing new physical therapy or participating in a weight loss or exercise program that has not been stable for at least 3 months prior to screening and won't remain stable during participation in study.
• •History or diagnosis of an inflammatory arthritis i.e. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
• •Known or clinically suspected infection and human immunodeficiency virus (HIV), or hepatitis C or B viruses.
• •History of abnormal laboratory results \> that or equal to 2.5 x upper limit of normal (ULN) indicative of any significant medical disease which in the opinion of the investigator, would preclude the subjects participation in the study.
• •Any of the following abnormal laboratory results during screening:
• •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> than or equal to 2.5 x ULN
• •Hemoglobin \< than 11.5 g/dL (female) or \< 13.2 g/dL (male)
• •White blood cell count (WBC) \< than 3500 cells/mm3
• •Lymphocyte count \< than or equal to 1000 cels/mm3
• •Serum creatinine \> than or equal 1.5 x ULN
• •Platelet count below the central laboratory lower limit of normal (LLN)
• •Coagulation tests (Prothrombin Time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR), Platelet Aggregation) requiring an alteration in anticoagulant dosage.
• •Skin breakdown or rash at knee where topical PENNSAID is to be applied.
• •Other serious uncontrolled non-malignant, significant, acute or chronic medical or psychiatric illness that, in judgment of investigator, could compromise subject safety, limit subject's ability to complete study and/or compromise the objectives of study.
• •History of malignancy in the past 5 years with exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
• •History of drug or alcohol dependence or abuse in the past 3 years.