Clinical trial NCT00790985: Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee
Official title: Phase 3. Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-severe Osteoarthritis (OA) of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Knee
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-11-14
Enrollment: 223
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Efficacy of flavocoxid 500 mg compared with naproxen 500 mg in subjects with moderate-severe osteoarthritis of the knee.

Eligibility 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 (cyclo-oxygenase-2) inhibitor in full therapeutic dose for at least one month prior to screening.
* Able and will to discontinue osteoarthritis medications until flare criteria met.
* BMI\</= 45
* Subjects must rate target knee at least 5 out of 10 on discomfort VAS (visual analogue scale) at baseline visit.
* Have an increase of at least 15mm on a 100mm pain VAS (visual analogue scale) 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
* Pregnant or lactating women
* History of serious cardio-vascular disease.
* Recurrent arrythmias, except paroxysmal tachycardia, cardiomyopathy, myocardial infarct 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.
* BMI\>45
* History of allergic reaction to flavonoid or flavan containing foods or products (example: red wine, colored fruits and vegetable, brazil 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.

Primary outcomes:
measure: Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12.
timeFrame: As measured at Baseline and Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AmeRuss Clinical Trials LLC, USA
name: Paul H Caldron, DO, FACP
role: STUDY_DIRECTOR
References: