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Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-severe Osteoarthritis of the Knee

This study has been completed.
Information provided by (Responsible Party):
Primus Pharmaceuticals Identifier:
First received: January 16, 2008
Last updated: October 19, 2015
Last verified: October 2015
To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.

Condition Intervention
Dietary Supplement: flavocoxid
Drug: Naproxen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3. Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-severe Osteoarthritis of the Knee

Resource links provided by NLM:

Further study details as provided by Primus Pharmaceuticals:

Enrollment: 220
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: flavocoxid 500 mg
flavonoid mixture
Dietary Supplement: flavocoxid
medical food
Other Name: limbrel
Active Comparator: naproxen
nonsteroidal anti-inflammatory drug
Drug: Naproxen
antiinflammatory drug
Other Name: naprosyn

Detailed Description:
Efficay of flavocoxid compared with naproxen in subjects with moderate-severe osteoarthritis of the knee.

Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Willing and able to read and understand informed consent and questionnaires in English.
  • Adults of either gender age 35-75 years, in general good health.
  • Established X-ray diagnosis of osteoarthritis of at least one knee.
  • Taken NSAID including COX-2 inhibitor in full therapeutic dose for at least one month prior to screening.
  • Able and will to discontinue OA medications until flare criteria met.
  • BMI</= 45
  • Subjects must rate target knee at least 5 out of 10 on discomfort VAS at baseline visit.
  • Have an increase of at least 15mm on a 100mm pain VAS from screening to baseline visit.
  • Must use acceptable birth control if female.
  • Screening fecal occult must be negative.
  • Able to attend all required visits
  • Physical Therapy is allowed as long as the type and frequency remains unchanged for the duration of the study.

Exclusion Criteria:

  • Refusal to sign consent.
  • Inability to attend all clinic visits
  • Grade 0-1 K-L changes in both knees or grade 4 K-L changes in either knee on standing A/P radiograph
  • Pregant or lactating women
  • History of serious cardio-vascular disease.
  • Recurrent arrythmias, except PAT, cardiomyopathy, MI within one year of screening.
  • History of chronic esophageal, gastric or duodenal disease
  • History of upper GI bleeding within the past 2 years.
  • Any GI disorder associated with malabsorption
  • Any musculo-skeletal or neurological condition that results in pain or gait disturbance that might confound evaluation of target knee.
  • Uncontrolled Diabetes Mellitus
  • History of bleeding disorder or concurrent use of coumadin or any agent used to reduce blood clotting or platelet adhesiveness.
  • Concurrent use of any anti-arthritic medication, including corticosteroids regardless of the reason for use. (low dose aspirin for cardioprotection is allowed)
  • History of chronic renal disease with creatinine >2.0 or nephrotic syndrome with 24 hour protein excretion >1000mg.
  • Intra-articular injection of any hyaluronic acid preparation in the target knee joint within 4 months of baseline visit.
  • Intra-articular injection of a corticosteroid in the target knee joint within 2 months of the baseline visit.
  • BMA>45
  • History of allergic reaction to flavonoid or flavan containg foods or products (example: red wine, colored fruits and vegetable, brazel nuts, tea, natto)
  • History of allergy to aspirin, naproxen or other NSAID
  • History of substance abuse including alcohol, or any psychiatric condition that may impair the subject's ability to comply with the study requirements.
  • Any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study.
  • Participation in another clinical trial within 30 days or 7 half lives of the study agent, whichever is longer, of the screening visit.
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Please refer to this study by its identifier: NCT00790985

Sponsors and Collaborators
Primus Pharmaceuticals
Study Director: Paul H Caldron, DO, FACP AmeRuss Clinical Trials LLC, USA
  More Information

Responsible Party: Primus Pharmaceuticals Identifier: NCT00790985     History of Changes
Other Study ID Numbers: LOA-04P
Study First Received: January 16, 2008
Last Updated: October 19, 2015

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017