Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)

Inclusion Criteria: * Male or non-pregnant female 18-75 years of age (inclusive) at the time of consent. * Must have a clinical diagnosis of moderate-to-severe CLBP for a minimum of 6 months prior to screening. * Must qualify for ATC opioid therapy for treatment of CLBP. * Must be classified as non-malignant and non-neuropathic (Class 1 and 2), neuropathic (Class 3), or symptomatic for more than 6 months after low back pain surgery (Class 9) based on the Quebec Task Force Scale score. * Female subjects of childbearing potential will use an acceptable method of birth control. * Must be in general good health based on screening physical examination. * Must be willing and able to comply with all study procedures and visit requirements. Exclusion Criteria: * Known to be refractory or intolerant to the analgesic effects of opioids or have failed previous opioid therapy. * A medical condition that would compromise the subject's ability to swallow, absorb, metabolize, or excrete the study drug, including (but not limited to) intractable nausea and/or vomiting and/or severe gastrointestinal narrowing (pathologic or iatrogenic), bowel obstruction, ileostomy, colostomy, or is suspected of having paralytic ileus. * A surgical procedure for back pain within 6 months prior to the Screening Visit. * Any other chronic pain condition other than CLBP that would interfere with the assessment of CLBP (e.g., osteoarthritis, rheumatoid arthritis, post-herpetic neuralgia, pain associated with diabetic neuropathy, fibromyalgia, migraine headaches requiring opioid therapy). * Known history of major depressive disorder that is not controlled with medication or has other conditions that produce significant cognitive or emotional disability. * Any clinically significant unstable medical abnormality or acute or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems. * Known history of alcohol and/or drug abuse. * Positive urine drug screen for illegal or non-prescribed drugs * Known history of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime during the subject's life except pediatric febrile seizures. * Known history of head injury within 6 months of Screening Visit. * Current malignancy or a history within past 2 years of malignancy, with the exception of basal cell carcinoma or cervical carcinoma in situ that have been successfully treated. * Positive for human …