This is a pilot study with a 4-period double-cross-over design evaluating a treatment with non-steroidal anti-inflammatory drugs (NSAIDs) in people with painful knee osteoarthritis.
Once screened and found eligible, participants will be entered into an initial blinded 2-week treatment period of either naproxen or placebo and then entered into an open washout period of 2 weeks. At the end of this washout, participants will then receive either naproxen or placebo for a further 2 week period followed again by a 2 week washout. This sequence will then be repeated (total of 4 treatment periods) such that all participants receive naproxen for 2 treatment periods and placebo for 2 treatment periods. The order of treatment will be randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
naproxen tablets
lactose NF
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Mean of one week's daily pain ratings on Numeric Pain Scale (NRS) 0-10; higher worse
daily pain will be collected by a web application and averaged over a 7day period; higher scores imply more pain
Time frame: baseline to end of 14 day treatment period
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