Open Label Assessment of Long-Term Safety and Utility

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904449
• Other study ID #: EN3202-022
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2009
• Last updated: February 9, 2010
• Start date: April 2001
• Est. completion date: December 2002

Study information

• Verified date: February 2010
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Oxymorphone ER
10mg, 20mg, and 40mg PO

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of AEs and clinical laboratory values		22 months	No
Secondary	Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer		22 months	No