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

Phase 3

Completed

• Conditions: Cancers, Pain; Lower Back Pain
• Interventions: Drug: Oxymorphone ER

• Registration Number: NCT00904280
• Lead Sponsor: Endo Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2003-07
• Study Completion: 2003-07
• Status Verified: 2009-03
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-18
• Last Update Submitted: 2009-05-18
• Study First Posted: 2009-05-19
• Last Update Posted: 2009-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxymorphone ER	Oxymorphone ER	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Arizona Clinical Research Center; 🇺🇸 Tucson, Arizona, United States