oxycodone deterx™ versus placebo in chronic low back pain (clbp)

Conditions: Chronic Low Back Pain

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.

Keywords: low back pain chronic back pain back pain opioid oxycodone deterx chronic pain chronic low back pain clbp xtampza