The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a 5-week dosing period in patients with osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
2 tablets BID
2 tablets BID
Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").
Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)
Time frame: 4 weeks
WOMAC Osteoarthritis Index, SF36
Osteoarthritis Index
Time frame: 4 weeks
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