Status:
COMPLETED
Flavocoxid, A Plant-Derived Therapy, for the Treatment of Knee Osteoarthritis
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Primus Pharmaceuticals
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
Brief Summary
Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed to treat arthritis. The purpose of this study is to test the effectiveness of flavocoxid, a plant-derived compound, for the treatm...
Detailed Description
OA is a leading chronic disease in older adults and is characterized by degeneration of articular cartilage of the joints in hands, spine, knees, and hips. In joints, tissue injury and pain are caused...
Eligibility Criteria
Inclusion
- Meet American College of Rheumatology (ACR) clinical criteria for knee OA
- In good medical and psychological health
- Able and willing to discontinue NSAIDs, natural therapies, and other pain medications for OA for 1 week prior to the first study visit and also throughout the course of the clinical trial
- Knee pain rated greater than 4 cm on a 10 cm visual analog scale (VAS)
- Intends to stay in the area and complete the 12-week protocol
- Willing to use acceptable forms of contraception
Exclusion
- Serious or unstable concomitant medical or psychological illnesses that would impair the patient's ability to complete the study
- Significant cardiac disease OR history of myocardial infarction in the 12 months prior to study entry
- Uncontrolled hypertension
- Significant bleeding disorders. Participants who have bleeding disorders related to uncontrolled, bleeding hemorrhoids occurring in the 12 months prior to study entry are not excluded.
- Uncontrolled gastrointestinal disease resulting in bleeding in the 60 days prior to study entry. Participants with controlled and uncomplicated ulcers are not excluded.
- Inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic pain syndrome
- Severe pes anserine bursitis, acute joint trauma, or complete loss of articular cartilage on the index knee
- Intravenous, intramuscular, or intra-articular steroids to the index joint within 60 days of study screening
- Alcohol, intravenous drug, or prescription drug abuse
- Investigational drugs within 30 days of study screening
- Current use of anticoagulants such as warfarin
- Oral corticosteroids or other immunosuppressants within 6 months of study screening
- Severe psoriasis requiring use of biologic immunomodulators such as alefacept, etanercept, infliximab, or cyclosporine
- Hypersensitivity to analgesics, cyclo-oxygenase inhibitors, lipoxygenase inhibitors, or flavonoids
- Pregnancy or breastfeeding
- Exclusion Criteria Postenrollment:
- Abnormal laboratory test results at study screening, as determined by the investigator
- Liver enzyme levels (SGOT, SGPT, alkaline phsphatase) two times the upper limit of normal
- Leukocyte counts less than 3.5 times 109/L or platelet counts less than 150 times 109/L
- At increased risk for cardiovascular problems based on the Framingham Cardiac Risk assessment questionnaire
- Kellgren/Lawrence radiographic score of 0, 1, or 4 on x-ray of index joint taken within 12 months of study entry
- Impaired renal function (creatinine greater than 1.5 mg/dl)
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00294125
Start Date
February 1 2006
End Date
November 1 2007
Last Update
April 22 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294