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Sponsors and Collaborators: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Primus Pharmaceuticals |
Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00294125 |
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.
Condition | Intervention | Phase |
Osteoarthritis |
Drug: Flavocoxid Drug: Placebo |
Phase I |
MedlinePlus related topics: | Osteoarthritis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Flavocoxid: A Medical Food Therapy for Osteoarthritis |
Estimated Enrollment: | 70 |
Study Start Date: | February 2006 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Participants will receive daily flavocoxid for 12 weeks.
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Drug: Flavocoxid
Daily flavocoxid for 12 weeks
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2: Placebo Comparator
Participants will receive placebo for 12 weeks.
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Drug: Placebo
Daily placebo for 12 weeks
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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.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria Postenrollment:
United States, Alabama | |||||
University of Alabama at Birmingham | |||||
Birmingham, Alabama, United States, 35294 |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Primus Pharmaceuticals |
Principal Investigator: | Sarah L. Morgan, MD, RD | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham ( Sarah L. Morgan, MD, RD ) |
Study ID Numbers: | R41 AR51232, 1-R41-AR051232-01A1 |
First Received: | February 16, 2006 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00294125 |
Health Authority: | United States: Federal Government |
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