Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Oxycodone DETERx; Placebo
Intervention description: 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h; Placebo, divided into 2 doses, q12h
Intervention MeSH terms: Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 740.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Low back pain; Chronic back pain; Back pain; Opioid; Oxycodone; DETERx; Chronic pain; Chronic low back pain; CLBP; Xtampza

Summary:

      The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared
      with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic
      low back pain requiring around-the-clock opioid analgesia for an extended period of time.
    

Eligibility criteria:

        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.