The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
873
2 tablets twice daily
2 tablets twice daily
Pain Intensity
Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)
Time frame: 12 weeks
Pain intensity difference (PID) from baseline to each scheduled evaluation
Time frame: 12 weeks
Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score
Time frame: 12 weeks
SF-36v2 Health Status Survey
Time frame: 12 weeks
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