NCT01511939

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

Single Center, Open-label Study of Effect of PENNSAID (Diclofenac Sodium Solution Topical) on Coagulation Parameters (PT, PTT, INR and Platelet Function) in Patients With Moderate to Severe Osteoarthritis Pain of the Knee Taking Anticoagulant Medication

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Nathan Wei, MD, FACP, FACR: · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis of the Knee
• Coagulopathy

Interventions

Type	Name	Description
DRUG	Pennsaid	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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-01-19
• Last updated: 2014-06-26
• Results posted: 2014-06-26

Locations

1 site across 1 country: United States