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

NCT ID: NCT00294125

Last Updated: 2013-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-11-30

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 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.

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 by the conversion of arachidonic acid to such inflammatory compounds as cyclooxygenases-1 and -2 (COX-1 and -2) and 5-lipoxygenase (5-LO). Conventional NSAIDs inhibit COX-1 and -2, but have little or no effect on 5-LO. NSAIDs provide relief from the pain of OA; however, NSAIDS are also associated with significant side effects, including gastrointestinal bleeding, venous thrombosis, and nephrotoxicity. Novel alternative therapies with increased safety and efficacy with fewer or no side effects are desirable; plant-derived substances might be useful alternatives to NSAIDs. Flavocoxid, a botanical extract derived from two plants, Scutellaria baicalensis and Acacia catechu, has been shown to inhibit COX-1 and -2 as well as 5-LO. The purpose of this study is to evaluate the safety and efficacy of flavocoxid in relieving the symptoms of knee OA in adults.

This study will last 12 weeks. Participants will be randomly assigned to one of two groups. Group 1 participants will receive daily flavocoxid; Group 2 participants will receive placebo. There will be 5 study visits: study entry and Weeks 2, 4, 8, and 12. Joint pain, tenderness, and swelling will be assessed at each study visit. A 30-foot timed walking test will also be performed at all visits. A physical exam and blood collection will occur at study entry and Week 12. Other study assessments will include safety monitoring, patient/physician global disease ratings, quality of life measures, depression and anxiety ratings, and measures of efficacy as determined by the Western Ontario and McMaster (WOMAC) OA index.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Participants will receive daily flavocoxid for 12 weeks.

Group Type: EXPERIMENTAL

Flavocoxid

Intervention Type: DRUG

Daily flavocoxid for 12 weeks

2

Participants will receive placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Daily placebo for 12 weeks

Interventions

Flavocoxid

Daily flavocoxid for 12 weeks

Intervention Type: DRUG

Placebo

Daily placebo for 12 weeks

Intervention Type: DRUG

Eligibility 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

• 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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Primus Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Sarah Morgan, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah L. Morgan, MD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

Morgan SL, Baggott JE, Moreland L, Desmond R, Kendrach AC. The safety of flavocoxid, a medical food, in the dietary management of knee osteoarthritis. J Med Food. 2009 Oct;12(5):1143-8. doi: 10.1089/jmf.2008.0244.

Reference Type: RESULT

PMID: 19857081 (View on PubMed)

Other Identifiers

R41AR051232

Identifier Type: NIH

Identifier Source: secondary_id

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1R41AR051232-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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R41AR051232

Identifier Type: NIH

Identifier Source: org_study_id

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