Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants
Condition: Osteoarthritis of the Knee; Coagulopathy
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Pennsaid
Intervention description: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period.
Intervention MeSH terms: Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Knee pain; Anticoagulant; Warfarin; Dabigatran; Clopidogrel; Aspirin; Topical NSAID; Osteoarthritis

Summary:

      The purpose of this study is to see if using a topical nonsteroidal antiinflammatory drug
      (Pennsaid) to treat osteoarthritis knee pain will affect coagulation values in patients who
      are also taking anticoagulant or antithrombotic medications.
    

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.