Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Primus Pharmaceuticals
Information provided by (Responsible Party):
Sarah Morgan, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00294125
First received: February 16, 2006
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Flavocoxid: A Medical Food Therapy for Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Safety and tolerability of flavocoxid (clinical status; causality and occurrence of adverse events) [ Time Frame: Measured throughout 12-week treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of treatment and clinical benefit [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

Enrollment: 59
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
Experimental: 1
Participants will receive daily flavocoxid for 12 weeks.
Drug: Flavocoxid
Daily flavocoxid for 12 weeks
Placebo Comparator: 2
Participants will receive placebo for 12 weeks.
Drug: Placebo
Daily placebo for 12 weeks

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294125

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Primus Pharmaceuticals
Investigators
Principal Investigator: Sarah L. Morgan, MD, RD University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Sarah Morgan, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00294125     History of Changes
Other Study ID Numbers: R41 AR51232, R41AR051232, 1-R41-AR051232-01A1
Study First Received: February 16, 2006
Last Updated: April 19, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
Medical Food
Botanicals
Phytochemicals

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014