Drug: Naproxen-matching placebo / Capsule
include, but are not limited to, the following
1. non-compliance with the numeric rating scale (nrs) recording during the
2. history or presence at the screening visit of non-oa inflammatory joint disease,
paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple
sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal
3. history or presence on imaging of arthropathy, neuropathic joint arthropathy, hip or
knee dislocation, extensive subchondral cysts, significant bone collapse or bone loss,
or pathologic fractures
4. trauma to the index joint within 3 months prior to the screening visit
5. signs or symptoms of carpal tunnel syndrome within 6 months of screening
6. patient is not a candidate for mri
7. is scheduled for a jr surgery to be performed during the study period or who would be
unwilling or unable to undergo jr surgery if needed
8. history or presence at the screening visit of autonomic or diabetic neuropathy, or
other peripheral neuropathy, including reflex sympathetic dystrophy
9. history or diagnosis of chronic autonomic failure syndrome including pure autonomic
failure, multiple system atrophy
10. history of naproxen intolerance, or existence of a medical condition that is high risk
for naproxen-associated complications
11. resting heart rate of <50 beats per minute (bpm) or >100 bpm at the screening or
12. history or presence of 2nd or 3rd degree heart block, 1st degree heart block with
abnormal complex of q, r, and s waves on an electrocardiogram (qrs) complex, or
bifascicular block by ecg assessment at the screening visit
13. history or presence of orthostatic hypotension at the screening, prerandomization, or
14. history of poorly controlled hypertension
15. use of systemic corticosteroid within 30 days prior to the screening visit.
intra-articular corticosteroids in the index joint within 12 weeks prior to the
screening visit, or to any other joint within 30 days prior to the screening visit
16. exposure to an anti-nerve growth factor (ngf) antibody prior to the screening visit or
known sensitivity or intolerance to anti-ngf antibodies
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