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

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ClinicalTrials.gov Identifier: NCT00294125
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : April 22, 2013
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Primus Pharmaceuticals
Information provided by (Responsible Party):
Sarah Morgan, MD, University of Alabama at Birmingham

February 16, 2006
February 20, 2006
April 22, 2013
February 2006
November 2007   (Final data collection date for primary outcome measure)
Safety and tolerability of flavocoxid (clinical status; causality and occurrence of adverse events) [ Time Frame: Measured throughout 12-week treatment period ]
Safety and tolerability of flavocoxid (measured throughout the study)
Complete list of historical versions of study NCT00294125 on ClinicalTrials.gov Archive Site
Efficacy of treatment and clinical benefit [ Time Frame: Measured at Week 12 ]
Efficacy of treatment (measured at Week 12)
Not Provided
Not Provided
 
Flavocoxid, A Plant-Derived Therapy, for the Treatment of Knee Osteoarthritis
Flavocoxid: A Medical Food Therapy for Osteoarthritis

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • Drug: Flavocoxid
    Daily flavocoxid for 12 weeks
  • Drug: Placebo
    Daily placebo for 12 weeks
  • Experimental: 1
    Participants will receive daily flavocoxid for 12 weeks.
    Intervention: Drug: Flavocoxid
  • Placebo Comparator: 2
    Participants will receive placebo for 12 weeks.
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
70
November 2007
November 2007   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00294125
R41AR051232( U.S. NIH Grant/Contract )
R41AR051232 ( U.S. NIH Grant/Contract )
1R41AR051232-01A1 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Sarah Morgan, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Primus Pharmaceuticals
Principal Investigator: Sarah L. Morgan, MD, RD University of Alabama at Birmingham
University of Alabama at Birmingham
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP