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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.
To compare the efficacy, safety, quality of life and economic impact of flavocoxid vs naproxen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flavocoxid 250 mg | Active Comparator | Medical Food product |
|
| Naproxen | Active Comparator | antiinflammatory |
|
| Placebo | Placebo Comparator | Placebo |
|
| flavocoxid 500 mg | Experimental | medical food product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavocoxid 500 mg | Dietary Supplement | flavonoid mixture |
|
| 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 |
| 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 |
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Inclusion Criteria:Major inclusión criteria:
Major exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan J Kivitz, MD | Recruiting Altoona Center for Clinical Research 1125 Old Rt 220 North Duncansville PA 16635 Phone 814-693-0300 Fax 814-693-0400 | Principal Investigator |
| Timothy S Truitt, MD | Recruiting MIMA Century Research Associates 65 E. Nasa Blvd Suite 106 Melbourne FL 32901 Phone 321-723-1203 Fax 321-725-3602 | Principal Investigator |
| Joy Schechtman, DO | Sun Valley Arthritis Ltd. 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623-362-9264 | Principal Investigator |
| David S Silver, MD | 8691 Wilshire Blvd Suite 301 Beverly Hills CA 90211 phone 310-657-9650 Fax 310-659-2841 | Principal Investigator |
| Nathan Wei, MD | Arthritis and Osteoporosis Center of Maryland71 Thomas Johnson Drive Frederick MD 21702 Phone 301-694-5800 Fax 301 694-0187 | Principal Investigator |
| Norman B Gayliss, MD | 2845 Aventura Blvd. Suite 100 Aventura FL 33180 Phone 305-932-4295 Fax 305-932-6335 | Principal Investigator |
| David A. McLain, MD | 2022 Brookwood Medical Center Drive Suite 211 Birmingham AL 35209 Phone 205-877-2555 Fax 205-877-2790 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alan Kivitz MD | Duncansville | Pennsylvania | 16635 | United States |
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| 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 |
|
|
| Placebo | Other | Placebo |
|
| flavocoxid 250 mg | Other | Medical food product |
|
|
Comparison of FS-36, subject tolerability VAS
| 6 months |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |