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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Primus Pharmaceuticals
• Treatments: Naproxen

Criteria

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
• 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.