Cancer Clinical Trial
Official title:
An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain
The purpose of this study is to determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.
The purpose of this study is to evaluate the analgesic effectiveness and tolerability of oxymorphone ER in the treatment of cancer or neuropathic pain. Opioid-naïve subjects are gradually titrated from oxymorphone ER 5 mg, every 12 hours (q12h). All other subjects are titrated to a stable dose (defined as pain scores ≥ 4 on BPI Question 5 on 3 of 5 consecutive days while receiving the same total daily dose of study medication including rescue) with tolerable side effects. Subjects could potentially receive therapy for up to 12 months after the first dose of study medication. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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