Conditions: Osteoarthritis of the Knee Coagulopathy
Keywords: Knee pain Anticoagulant Warfarin Dabigatran Clopidogrel Aspirin Topical NSAID Osteoarthritis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 22
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Pennsaid 1.5%, 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 in a subject who has been taking a stable dose of warfarin for at least 2 months arm 2: Pennsaid 1.5%, 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 in a subject who has been taking a stable dose of dabigatran for at least 2 months arm 3: Pennsaid 1.5%, 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 in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months

Interventions: intervention 1: Pennsaid
Intervention descriptions: intervention 1: 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.

Protocol document: