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 immunodeficiency virus (HIV) or hepatitis B surface antigen, or
hepatitis C antibody

- Subject is not able or is unwilling to meet the study attendance requirements.

Other protocol specific inclusion and exclusion criteria may apply.