Flavocoxid, A Plant-Derived Therapy, for the Treatment of Knee Osteoarthritis

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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 treatment of knee osteoarthritis (OA) in adults.

Study hypotheses: 1) Flavocoxid has an acceptable safety and tolerability profile as determined by the Generally Regarded as Safe (GRAS) profile in patients with OA compared to identical placebo. 2) Flavocoxid will be more effective as a therapy for OA compared to identical placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Primus Pharmaceuticals

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)