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

Endo Pharmaceuticals0 sites24 target enrollmentApril 2001

ConditionsPain

InterventionsOxymorphone ER

DrugsOxymorphone ER

Overview

Phase: Phase 3
Intervention: Oxymorphone ER
Conditions: Pain
Sponsor: Endo Pharmaceuticals
Enrollment: 24
Primary Endpoint: Assessment of AEs and clinical laboratory values
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 monitor the long-term analgesic effectiveness, safety, and utility of oxymorphone ER for the relief of moderate to severe pain due to cancer.

Registry

clinicaltrials.gov

Start Date

April 2001

End Date

December 2002

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Endo Pharmaceuticals

Eligibility Criteria

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.