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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