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.

Endo Pharmaceuticals1 site in 1 country239 target enrollmentMarch 2001

ConditionsCancers, Pain Lower Back Pain

InterventionsOxymorphone ER

DrugsOxymorphone ER

Overview

Phase: Phase 3
Intervention: Oxymorphone ER
Conditions: Cancers, Pain
Sponsor: Endo Pharmaceuticals
Enrollment: 239
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2001

End Date

July 2003

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Endo Pharmaceuticals

Eligibility Criteria

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-
•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.

Arms & Interventions

Oxymorphone ER

Intervention: Oxymorphone ER

Outcomes

Primary Outcomes

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

Time Frame: 1 year study

Secondary Outcomes

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)