An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy of Numorphan® CR (Oxymorphone HCL Controlled Release) in Subjects With Cancer Pain or Chronic Lower Back Pain.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Monthly assessments of pain with the Brief Pain Inventory (BPI) questionnaire, recall of average pain relief, total rescue medication usage and subject's and physician's global assessment of oxymorphone ER
1 year study
No
Sr. Director
Study Director
Endo Pharmaceuticals
United States: Food and Drug Administration
EN3202-021
NCT00904280
March 2001
July 2003
Name | Location |
---|---|
Arizona Clinical Research Center | Tucson, Arizona 85712 |