Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy

May 18, 2009 updated by: Endo Pharmaceuticals

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States
        • Arizona Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxymorphone ER
Drug: Oxymorphone ER
Open label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

July 1, 2003

Study Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 19, 2009

Study Record Updates

Last Update Posted (Estimate)

May 19, 2009

Last Update Submitted That Met QC Criteria

May 18, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN3202-021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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