Status:
COMPLETED
Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study
Lead Sponsor:
Primus Pharmaceuticals
Conditions:
Osteoarthritis
Eligibility:
All Genders
30-85 years
Phase:
NA
Brief Summary
safety, efficacy and acceptability of Flavocoxid
Detailed Description
Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects with Osteoarthritis of the Knee. A Pilot Study
Eligibility Criteria
Inclusion
- OA of the knee,K-L grade 2-3 in general good health is currently taking an NSAID or COX-2 inhibitor -
Exclusion
- 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
- \-
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00303017
Start Date
March 1 2006
End Date
September 1 2006
Last Update
October 21 2015
Active Locations (1)
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1
Timothy Truitt MD
Melbourne, Florida, United States, 32901