Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy
CompletedPhase 3NCT00904280
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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.
- Conditions
- Cancers, Pain
- Lower Back Pain
- Interventions
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Start date
- 2001-03
- Primary completion
- 2003-07
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00904280