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| Sponsored by: |
Primus Pharmaceuticals |
|---|---|
| Information provided by: | Primus Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00303017 |
Purpose
safety, efficacy and acceptability of Flavocoxid
| Condition | Intervention |
|---|---|
|
Osteoarthritis |
Drug: Flavocoxid ( Medical Food) |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Safety, Efficacy and Acceptability of Flavocoxid (Limbrel) Compared With Naproxen in Subjects With Osteoarthritis of the Knee. A Pilot Study |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2006 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects with Osteoarthritis of the Knee. A Pilot Study
Eligibility| Ages Eligible for Study: | 30 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
-
Contacts and Locations| United States, Florida | |
| Timothy Truitt MD | |
| Melbourne, Florida, United States, 32901 | |
| Principal Investigator: | 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 |
More Information
| Study ID Numbers: | Primus Protocol #OAPS |
| Study First Received: | March 13, 2006 |
| Last Updated: | November 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00303017 |
| Health Authority: | United States: Primus Pharmaceuticals, Inc |
|
Osteoarthritis, Knee Naproxen Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |
