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 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerability
Throughout the study
Yes
Study Director
Study Director
Endo Pharmaceuticals
United States: Food and Drug Administration
EN3202-029
NCT00911261
August 2003
May 2005
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