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safety, efficacy and acceptability of Flavocoxid
Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects with Osteoarthritis of the Knee. A Pilot Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flavocoxid | Experimental | medical food |
|
| naproxen | Active Comparator | NSAID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flavocoxid | Dietary Supplement | flavonoid mixture |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| compare efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate safety |
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Inclusion Criteria:
OA of the knee,K-L grade 2-3 in general good health is currently taking an NSAID or COX-2 inhibitor -
Exclusion Criteria:
pregant or nursing women grade 1 or 4 OA any significant medical condition that in the opinion of the physician might put the subject at risk in this study any form of arthropathy other than OA any condition that might confound the evaluation of the pain, stiffness or function of the target joint intra-articular cotticosteroid inkection in the target joint within 3 month of the screening visit concomitant use of other anti-inflammatory or anti arthritic medication or products(including OTC and herbal preparations) Low dose aspirin for cardio-protection is allowed concomitant use of coumadin or other anticoagulant or anti-platelet medication concomitant use of gastro-protectiv medications including, but not limited to, H2 blockers and proton pump inhibitors, including OTC and herbal products History of allergy to Flavonoids
-
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| Name | Affiliation | Role |
|---|---|---|
| Joy Schechtman, DO | Sun Valley Arthritis Ltd, 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623 | Principal Investigator |
| Timothy Truitt, MD | MIMA Century Research Associates 65 E. Nasa Blvd. Suite 106 Melbourne FL 32901 Phone 321 723-1203 Fax 321-725-3602 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Timothy Truitt MD | Melbourne | Florida | 32901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19555810 | Derived | Levy RM, Saikovsky R, Shmidt E, Khokhlov A, Burnett BP. Flavocoxid is as effective as naproxen for managing the signs and symptoms of osteoarthritis of the knee in humans: a short-term randomized, double-blind pilot study. Nutr Res. 2009 May;29(5):298-304. doi: 10.1016/j.nutres.2009.04.003. |
| Label | URL |
|---|---|
| Primus Pharmaceuticals, Inc | View source |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C544478 | flavocoxid |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Naproxen | Drug | non-steroidal anti-inflammatory drug |
|
|
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |