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

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904280
First received: May 15, 2009
Last updated: May 18, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Cancers, Pain
Lower Back Pain
Drug: Oxymorphone ER
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate long-term efficacy of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain [ Time Frame: 1 year study ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: March 2001
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxymorphone ER
N/A
Drug: Oxymorphone ER
Open label

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 EN3202-019.
  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00904280

Locations
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Sr. Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr. Director, Cliniacal R&D, Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00904280     History of Changes
Other Study ID Numbers: EN3202-021
Study First Received: May 15, 2009
Last Updated: May 18, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics
Oxymorphone
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Analgesics, Opioid
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 24, 2014