Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy
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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.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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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 [ Time Frame: 1 year study ]
Secondary Outcome Measures :
To evaluate long-term efficacy of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain [ Time Frame: 1 year study ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The subject enrolled in this study must have been previously randomized and dosed in the double-blind treatment period of study EN3202-016 or EN3202-019 and completed the exit visits for these studies.
Males or females, age 18 and 75 years, inclusively.
The subject continues to have chronic moderate to severe back or cancer pain that requires opioid medication. Women must continue to be of non-childbearing potential.
The subject experienced any serious drug related adverse events in studies EN3202-016 or EN3202-019.
The subject withdrew from EN3202-016 or EN3202-019 for a reason other than lack of efficacy.
Subjects with known allergies to opiate-class narcotic agents (morphine, codeine, hydrocodone, propoxyphene, meperidine, oxycodone, etc.) or naproxen, or subjects who have any medical condition in which opiates are medically contraindicated.