Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy
Overview
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.
Full Title of Study: “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 Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 2003
Interventions
- Drug: Oxymorphone ER
- Open label
Arms, Groups and Cohorts
- Experimental: Oxymorphone ER
Clinical Trial Outcome Measures
Primary Measures
- 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 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
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Endo Pharmaceuticals
- Provider of Information About this Clinical Study
- Sr. Director, Cliniacal R&D, Endo Pharmaceuticals
- Overall Official(s)
- Sr. Director, Study Director, Endo Pharmaceuticals
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