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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 (ATCCTCP-1)
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.
Details
| Lead sponsor | Nathan Wei, MD, FACP, FACR: |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 22 |
| Start date | 2012-02 |
| Completion | 2013-05 |
Conditions
- Osteoarthritis of the Knee
- Coagulopathy
Interventions
- Pennsaid
Primary outcomes
- Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT) — Baseline to week 4
PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters. - Change From Baseline to Week 4 in Laboratory Results of International Normalized Ratio (INR) — Baseline to Week 4
INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters. - Change From Baseline to Week 4 in Laboratory Results of Partial Thromboplastin Time (PTT) — Baseline to Week 4
PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters. - Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation — Baseline to Week 4
Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Countries
United States