Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy

Lower Back Pain Clinical Trial

Official title:

An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy of Numorphan® CR (Oxymorphone HCL Controlled Release) in Subjects With Cancer Pain or Chronic Lower Back Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904280
• Other study ID #: EN3202-021
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2009
• Last updated: May 18, 2009
• Start date: March 2001
• Est. completion date: July 2003

Study information

• Verified date: March 2009
• 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 evaluate the long-term safety and tolerability of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: July 2003
• Est. primary completion date: July 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The subject enrolled in this study must have been previously randomized and dosed in the double-blind treatment period of study EN3202-016 or EN3202-019 and completed the exit visits for these studies.

• Males or females, age 18 and 75 years, inclusively.

• The subject continues to have chronic moderate to severe back or cancer pain that requires opioid medication. Women must continue to be of non-childbearing potential.

Exclusion Criteria:

• The subject experienced any serious drug related adverse events in studies EN3202-016 or EN3202-019.

• The subject withdrew from EN3202-016 or EN3202-019 for a reason other than lack of efficacy.

• Subjects with known allergies to opiate-class narcotic agents (morphine, codeine, hydrocodone, propoxyphene, meperidine, oxycodone, etc.) or naproxen, or subjects who have any medical condition in which opiates are medically contraindicated.

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Cancers, Pain
• Low Back Pain
• Lower Back Pain

Intervention

Drug:
• Oxymorphone ER
Open label

Locations

Country	Name	City	State
United States	Arizona Clinical Research Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monthly assessments of pain with the Brief Pain Inventory (BPI) questionnaire, recall of average pain relief, total rescue medication usage and subject's and physician's global assessment of oxymorphone ER		1 year study	No
Secondary	To evaluate long-term efficacy of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain		1 year study	No