Status:
COMPLETED
Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Cancers, Pain
Lower Back Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00904280
Start Date
March 1 2001
End Date
July 1 2003
Last Update
May 19 2009
Active Locations (1)
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1
Arizona Clinical Research Center
Tucson, Arizona, United States