This is a study of the safety and pain-relieving ability of extended release hydrocodone and acetaminophen tablets in patients with moderate to severe low back pain
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
770
Pain Intensity Difference from randomization baseline to each subject's final assessment
Pain intensity difference assessed by the Chronic Low Back Pain Intensity Score (100mm Visual Analog Scale)
Time frame: 12 Weeks
Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period
Pain Intensity Difference from randomization baseline to each scheduled assessment
Global Assessments of Study Drug and Back Pain Status
Roland-Morris Disability Questionnaire
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