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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.


Phase 3
18 Years
75 Years
Not Enrolling
Both
Cancers, Pain, Lower Back Pain

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

1 year study

Safety Issue:

No

Principal Investigator

Sr. Director

Investigator Role:

Study Director

Investigator Affiliation:

Endo Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

EN3202-021

NCT ID:

NCT00904280

Start Date:

March 2001

Completion Date:

July 2003

Related Keywords:

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

Name

Location

Arizona Clinical Research CenterTucson, Arizona  85712