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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00790985
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : October 21, 2015
Information provided by (Responsible Party):
Primus Pharmaceuticals

Brief Summary:
To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis Dietary Supplement: flavocoxid Drug: Naproxen Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : January 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00790985

Sponsors and Collaborators
Primus Pharmaceuticals
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Study Director: Paul H Caldron, DO, FACP AmeRuss Clinical Trials LLC, USA
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Responsible Party: Primus Pharmaceuticals Identifier: NCT00790985    
Other Study ID Numbers: LOA-04P
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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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