Clinical trial: Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants (NCT01511939)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female adults > than or equal to 55

          -  Ambulatory subjects with moderate to severe osteoarthritis (OA) of the knee with
             symptoms and knee pain for at least 3 months and pain on the majority of days in the
             last 30 days.

          -  Subjects with bilateral knee OA, the more symptomatic knee is the index knee and
             PENNSAID can be applied on both knees if both are affected.

          -  Radiographic evidence of Kellgren-Lawrence Grade 2-4 within the past 2 years.

          -  Currently on a stable dose of anticoagulant therapy (warfarin, dabigatran, aspirin or
             clopidogrel) for the past 2 months and expected to remain on current dose for the six
             week duration of the study.

          -  If currently taking oral nonsteroidal antiinflammatory drug (NSAID) and/or
             acetaminophen for OA knee pain, must be taking it for at least an average of 25 days
             per month.

          -  Those currently taking oral NSAID must be willing to perform a 7 day washout to be
             eligible to be enrolled into the study.

          -  A pain score of > than 40mm on the Patient Pain Visual Analog Scale (VAS) (100 mm
             scale) at screening and baseline visit.

          -  Able to comply with the study and give informed consent prior to performance of any
             study procedures.

          -  Able to read, write and understand English.

        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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Contradiction