Status:
COMPLETED
Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants
Lead Sponsor:
Nathan Wei, MD, FACP, FACR:
Collaborating Sponsors:
Medtronic - MITG
Arthritis Treatment Center, Maryland
Conditions:
Osteoarthritis of the Knee
Coagulopathy
Eligibility:
All Genders
55+ years
Phase:
PHASE3
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 an...
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 yea...
Eligibility Criteria
Inclusion
- Male or female adults \> than or equal to 55
- Ambulatory subjects with moderate to severe osteoarthritis (OA) of the knee with symptoms and knee pain for at least 3 months and pain on the majority of days in the last 30 days.
- Subjects with bilateral knee OA, the more symptomatic knee is the index knee and PENNSAID can be applied on both knees if both are affected.
- Radiographic evidence of Kellgren-Lawrence Grade 2-4 within the past 2 years.
- Currently on a stable dose of anticoagulant therapy (warfarin, dabigatran, aspirin or clopidogrel) for the past 2 months and expected to remain on current dose for the six week duration of the study.
- If currently taking oral nonsteroidal antiinflammatory drug (NSAID) and/or acetaminophen for OA knee pain, must be taking it for at least an average of 25 days per month.
- Those currently taking oral NSAID must be willing to perform a 7 day washout to be eligible to be enrolled into the study.
- A pain score of \> than 40mm on the Patient Pain Visual Analog Scale (VAS) (100 mm scale) at screening and baseline visit.
- Able to comply with the study and give informed consent prior to performance of any study procedures.
- Able to read, write and understand English.
Exclusion
- Unwilling to abstain from oral NSAIDs and/or other analgesic medication except for acetaminophen as rescue medication. Subjects taking low dose aspirin for cardiovascular health may remain on their stable dose throughout the study.
- Unwilling to abstain from taking \< than or equal to 1500mg of acetaminophen a day for rescue medication purposes during the 6 week course of the trial.
- Using a handicap assistance device i.e. cane, walker \> than or equal to 50% of the time.
- Undergoing new physical therapy or participating in a weight loss or exercise program that has not been stable for at least 3 months prior to screening and won't remain stable during participation in study.
- History or diagnosis of an inflammatory arthritis i.e. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
- Known or clinically suspected infection and human immunodeficiency virus (HIV), or hepatitis C or B viruses.
- History of abnormal laboratory results \> that or equal to 2.5 x upper limit of normal (ULN) indicative of any significant medical disease which in the opinion of the investigator, would preclude the subjects participation in the study.
- Any of the following abnormal laboratory results during screening:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> than or equal to 2.5 x ULN
- Hemoglobin \< than 11.5 g/dL (female) or \< 13.2 g/dL (male)
- White blood cell count (WBC) \< than 3500 cells/mm3
- Lymphocyte count \< than or equal to 1000 cels/mm3
- Serum creatinine \> than or equal 1.5 x ULN
- Platelet count below the central laboratory lower limit of normal (LLN)
- Coagulation tests (Prothrombin Time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR), Platelet Aggregation) requiring an alteration in anticoagulant dosage.
- Skin breakdown or rash at knee where topical PENNSAID is to be applied.
- Other serious uncontrolled non-malignant, significant, acute or chronic medical or psychiatric illness that, in judgment of investigator, could compromise subject safety, limit subject's ability to complete study and/or compromise the objectives of study.
- History of malignancy in the past 5 years with exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
- History of drug or alcohol dependence or abuse in the past 3 years.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01511939
Start Date
February 1 2012
End Date
May 1 2013
Last Update
June 26 2014
Active Locations (1)
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1
Arthritis Treatment Center
Frederick, Maryland, United States, 21702