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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00790985
• Date of registration: 16/01/2008
• Primary sponsor: Primus Pharmaceuticals
• Public title: Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
• Scientific title: Phase 3. Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
• Date of first enrolment: January 2008
• Target sample size: 250
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00790985
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Contacts

• Name: Paul H Caldron, DO, FACP
• Affiliation: AmeRuss Clinical Trials LLC USA

Key inclusion & exclusion 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.



Age minimum: 35 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoarthritis

Intervention(s)

Other: flavocoxid

Secondary ID(s)

LOA-04P

Source(s) of Monetary Support

Please refer to primary and secondary sponsors