An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain

Endo Pharmaceuticals0 sites223 target enrollmentAugust 2003

ConditionsChronic Pain Neuropathic Pain Cancer

InterventionsOxymorphone Extended Release

DrugsOxymorphone Extended Release

Overview

Phase: Phase 3
Intervention: Oxymorphone Extended Release
Conditions: Chronic Pain
Sponsor: Endo Pharmaceuticals
Enrollment: 223
Primary Endpoint: Tolerability
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.

Detailed Description

The purpose of this study is to evaluate the analgesic effectiveness and tolerability of oxymorphone ER in the treatment of cancer or neuropathic pain. Opioid-naïve subjects are gradually titrated from oxymorphone ER 5 mg, every 12 hours (q12h). All other subjects are titrated to a stable dose (defined as pain scores ≥ 4 on BPI Question 5 on 3 of 5 consecutive days while receiving the same total daily dose of study medication including rescue) with tolerable side effects. Subjects could potentially receive therapy for up to 12 months after the first dose of study medication.

Registry

clinicaltrials.gov

Start Date

August 2003

End Date

May 2005

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Endo Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•≥ 18 years of age or older, with moderate to severe chronic malignant and/or neuropathic pain of at least 3 months duration and either:
•have an initial pain intensity score of greater than 4 on a 10-point scale using BPI Question 5, if sub-optimally responding to their current analgesic regimen, or
•have intolerable side effects to one or more components of their current opioid-containing analgesic regimen.
•Currently receive a stable (at least 2 weeks duration) analgesic regimen
•If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method).
•Understand written and spoken English
•Have been informed of the nature of the study and provided written informed consent
•Additional Inclusion Criteria for Cancer Patients Only:
•Have a life expectancy of at least 12 months
•Additional Inclusion Criteria for Neuropathic Patients Only:

Exclusion Criteria

•Have a positive pregnancy test (females only)
•Have a history of or active asthma or emphysema
•Have clinically significant hepatic impairment
•Have a history of alcohol or substance abuse within the last 3 years
•Have a history of opioid abuse within 6 months prior to study entry
•Have a known allergy or significant reaction to opioids, including codeine
•Have a known oxymorphone sensitivity or allergy
•Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication