Title
Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study
Safety, Efficacy and Acceptability of Flavocoxid (Limbrel) Compared With Naproxen in Subjects With Osteoarthritis of the Knee. A Pilot Study
Phase
N/ALead Sponsor
Primus PharmaceuticalsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
OsteoarthritisIntervention/Treatment
naproxen tj-14 epicatechin ...Study Participants
60safety, 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
flavonoid mixture
non-steroidal anti-inflammatory drug
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 -