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

Endo Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Lower Back Pain

Cancers, Pain

Treatments

Drug: Oxymorphone ER

Study type

Interventional

Funder types

Industry

Identifiers

NCT00904280

EN3202-021

Details and patient eligibility

About

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.

Enrollment

239 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.