Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

Study Overview
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Brief Summary
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The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with Naproxen and placebo in OA of the knee.

Detailed Description
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To compare the efficacy, safety, quality of life and economic impact of flavocoxid vs naproxen.

Official Title
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A Double-Blind,Randomized, Placebo Controlled, Parallel Group, Multi-Center Study of Flavocoxid (Limbrel) Versuss Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

Conditions
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Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: Flavocoxid 500 mg
* Drug: Naproxen
* Other: Placebo
* Other: flavocoxid 250 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Major inclusión criteria: Adults of either gender, ages 35-85, in general good health Diagnosed with OA of the knee, K-L Grade 2-3 History of positive response to NSAID's or COX-2 inhibitors Able and willing to discontinue other medicinal OA therapies for length of the study (subjects may continue low dose aspirin for cardioprotection) Females of child bearing potential must use acceptable method of birth control Major exclusion criteria: Unwilling or unable to read and sign informed consent document Pregnant and nursing women History of severe cardiovascular disease including, but not limited to chronic angina, congestive heart failure, uncontrolled hypertension, acute myocardial infarction within past year K-L grade 1 or 4 OA of the target knee chronic bleeding disorder or present use of anticoagulants History of upper G-I bleed in the past 5 years Significant renal disease including nephrotic syndrome, proteinuria >1 gm/24 hrs or serum Creatinine >2.0 Any arthritic disease that is or has the potential to affect the knees during the course of the study Any other condition that might confound evaluation of the target joint including, but not limited to, bursitis, tendonitis or internal derangement in or about the knee, gait disturbances (e.g. mechanical, neurological conditions or disorders of the back), fibromyalgia, polyneuropathies, etc.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: flavocoxid 250 mg<br>Medical Food product | Other: flavocoxid 250 mg<br>* Medical food product<br>* Other names: Limbrel 250 mg;|
| Active Comparator: Naproxen<br>antiinflammatory | Drug: Naproxen<br>* non-steroidal anti-inflammatory drug<br>* Other names: naprosyn;|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo<br>|
| Experimental: flavocoxid 500 mg<br>medical food product | Dietary Supplement: Flavocoxid 500 mg<br>* flavonoid mixture<br>* Other names: Limbrel 500 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks | comparison of short WOMAC and timed walk | 3 months | 
| to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks | Comparison of FS-36, subject tolerability VAS | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks | comparison of short WOMAC and timed walk | 6 months | 
| to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks | Comparison of FS-36, subject tolerability VAS | 6 months |