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

Completed · Phase 3

Conditions studied: Cancers, Pain, Lower Back Pain

In brief

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.

Key facts

Study ID

NCT00904280

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

239

Starts

2001-03-01

Expected to finish

2003-07-01

Last updated by the study team

2009-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Clinical Research Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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