At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 22 enrolled
Drug / intervention
Pennsaiddrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Pennsaid for Osteoarthritis of the Knee and Coagulopathy. Completed, enrolled 22 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Knee, Coagulopathy
CountriesUnited States
CollaboratorsMedtronic - MITG, Arthritis Treatment Center, Maryland
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 2012
Enrollment StartFeb 2012
Primary CompletionMay 2013
TodayJul 2026
First PostedJan 19, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.5 years ago
Interventions
Pennsaiddrug
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.