Open Label Assessment of Long-Term Safety and Utility

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Oxymorphone ER

• Registration Number: NCT00904449
• Lead Sponsor: Endo Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-15
• Study First Posted: 2009-05-19
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-09
• Last Update Posted: 2010-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label	Oxymorphone ER	-

Primary Outcome Measures

Name	Time	Method
Assessment of AEs and clinical laboratory values	22 months

Secondary Outcome Measures

Name	Time	Method
Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer	22 months