Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study
- Conditions
- Osteoarthritis
- Interventions
- Dietary Supplement: flavocoxid
- Registration Number
- NCT00303017
- Lead Sponsor
- Primus Pharmaceuticals
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
OA of the knee,K-L grade 2-3 in general good health is currently taking an NSAID or COX-2 inhibitor -
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description flavocoxid flavocoxid medical food naproxen Naproxen NSAID
- Primary Outcome Measures
Name Time Method compare efficacy
- Secondary Outcome Measures
Name Time Method evaluate safety
Trial Locations
- Locations (1)
Timothy Truitt MD
🇺🇸Melbourne, Florida, United States