To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.
Efficacy of flavocoxid 500 mg compared with naproxen 500 mg in subjects with moderate-severe osteoarthritis of the knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
223
medical food
antiinflammatory drug
Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12.
WOMAC is a composite of subscales: pain - 5 questions, stiffness - 2 questions, physical function - 17 questions. Subject answers each question as none=0, slight=1, moderate=2, very=3 and extreme=4 of pain, stiffness and difficulty of function. Scores for each subscale are summed, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).The higher the score of the units on the scale, the better the outcome. For each individual subject, the percent change from baseline to Week 12 in the WOMAC composite score is calculated as 100 x (week 12 minus baseline)/baseline. The higher the percent change, the better the outcome. The percent changes from baseline to Week 12 are then compared between Flavocoxid and Naproxen.
Time frame: As measured at Baseline and Week 12
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