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.
Open-label active treatment Phase III study of Pennsaid (diclofenac sodium 1.5% topical solution) to determine the effects on coagulation parameters in patients who are equal to or greater than 55 years of age with moderate to severe osteoarthritis knee pain and who are also taking warfarin, dabigatran, or aspirin and/or clopidogrel.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
22
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.
Arthritis Treatment Center
Frederick, Maryland, United States
Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT)
PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Time frame: Baseline to week 4
Change From Baseline to Week 4 in Laboratory Results of International Normalized Ratio (INR)
INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Time frame: Baseline to Week 4
Change From Baseline to Week 4 in Laboratory Results of Partial Thromboplastin Time (PTT)
PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Time frame: Baseline to Week 4
Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation
Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Time frame: Baseline to Week 4
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