Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy
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.
1 other identifier
interventional
239
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2001
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 15, 2009
CompletedFirst Posted
Study publicly available on registry
May 19, 2009
CompletedMay 19, 2009
March 1, 2009
2.3 years
May 15, 2009
May 18, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To evaluate long-term efficacy of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain
1 year study
Study Arms (1)
Oxymorphone ER
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arizona Clinical Research Center
Tucson, Arizona, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sr. Director
Endo Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 15, 2009
First Posted
May 19, 2009
Study Start
March 1, 2001
Primary Completion
July 1, 2003
Study Completion
July 1, 2003
Last Updated
May 19, 2009
Record last verified: 2009-03