Open Label Assessment of Long-Term Safety and Utility

February 9, 2010 updated by: Endo Pharmaceuticals

An Open-Label Assessment of the Long-Term Safety and Utility of Numorphan® for the Relief of Moderate to Severe Pain in Patients With Cancer

The purpose of this study is to monitor the long-term analgesic effectiveness, safety, and utility of oxymorphone ER for the relief of moderate to severe pain due to cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females aged > 18 years with moderate to severe pain arising from cancer (histologically and/or clinically proven) who require chronic treatment with WHO step 3 analgesics.
  • Women of child-bearing potential must be using an approved method of contraception (hormone contraception, IUD, or double barrier method) and have a negative serum pregnancy test prior to entry into the study.
  • Participated in study EN3202-018; the patient must have been treated with study medication and completed the exit visit to be eligible.

Exclusion Criteria:

  • Experienced a serious, adverse experience during study EN3202-018 that was possible or probably related to study medication.
  • Withdrew from study EN3202-018 due to an Adverse experience possibly or probably related to study medication.
  • Known idiosyncratic reaction or hypersensitivity to oxymorphone.
  • Inability to take oral medication for 1 week.
  • Patients with ileosomy, mechanical intestinal obstruction, partial or complete gastric outlet obstruction, parlayticileus, or other conditions that might contraindicate the use of, or impair the absorption of an oral controlled-release dosage form.

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: Open Label
Drug: Oxymorphone ER
10mg, 20mg, and 40mg PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of AEs and clinical laboratory values
Time Frame: 22 months
22 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer
Time Frame: 22 months
22 months

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

April 1, 2001

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria

May 15, 2009

First Posted (Estimate)

May 19, 2009

Study Record Updates

Last Update Posted (Estimate)

February 10, 2010

Last Update Submitted That Met QC Criteria

February 9, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN3202-022

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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