Summary:
A study design to assess the efficacy and safety of oxycodone/naloxone controlled-release tablets (oxn) compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain.
Qualified Participants Must:
• Be 18 years of age or older
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Have moderate to severe chronic low back pain lasting at least several hours daily for at least 3 months prior to screening
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Have back pain related to nonmalignant and nonneuropathic conditions and without radiation or only above the knee radiation
•
Be on opioid analgesic therapy for low back pain which has been ongoing for at least 4 weeks prior to screening
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Be likely to benefit from chronic around-the-clock opioid therapy for the duration of the study
Qualified Participants May Receive:
All study-related medications, all study-related medical care at no cost, and compensation for time and travel.