Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00911261
First received: May 15, 2009
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

The purpose of this study is to determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.


Condition Intervention Phase
Chronic Pain
Neuropathic Pain
Cancer
Drug: Oxymorphone Extended Release
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 Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Tolerability [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Average daily pain intensity (Question 5 of BPI) [ Time Frame: Week 1-4, Month 12 ] [ Designated as safety issue: No ]
  • Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire [ Time Frame: Week 1-4, Month 12 ] [ Designated as safety issue: No ]
  • Average daily dose of oxymorphone ER [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Average daily dose of rescue medication [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Total daily dose of oxymorphone ER and rescue medication [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Time to stabilization [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Patient/investigator global assessment of pain relief [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Treatment Satisfaction [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Enrollment: 223
Study Start Date: August 2003
Study Completion Date: May 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: Oxymorphone Extended Release
  • Study Medication: Oxymorphone ER 5 mg, 10 mg, 20 mg, and 40 mg tablets
  • Rescue Medication: Oxymorphone IR 5 mg and 10 mg tablets
  • Treatment will consist of up to 12 months of dosing with Oxymorphone ER.

Detailed Description:

The purpose of this study is to evaluate the analgesic effectiveness and tolerability of oxymorphone ER in the treatment of cancer or neuropathic pain. Opioid-naïve subjects are gradually titrated from oxymorphone ER 5 mg, every 12 hours (q12h). All other subjects are titrated to a stable dose (defined as pain scores ≥ 4 on BPI Question 5 on 3 of 5 consecutive days while receiving the same total daily dose of study medication including rescue) with tolerable side effects. Subjects could potentially receive therapy for up to 12 months after the first dose of study medication.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years of age or older, with moderate to severe chronic malignant and/or neuropathic pain of at least 3 months duration and either:

    1. have an initial pain intensity score of greater than 4 on a 10-point scale using BPI Question 5, if sub-optimally responding to their current analgesic regimen, or
    2. have intolerable side effects to one or more components of their current opioid-containing analgesic regimen.
  • Currently receive a stable (at least 2 weeks duration) analgesic regimen
  • If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method).
  • Understand written and spoken English
  • Have been informed of the nature of the study and provided written informed consent

Additional Inclusion Criteria for Cancer Patients Only:

  • Have a life expectancy of at least 12 months

Additional Inclusion Criteria for Neuropathic Patients Only:

  • Have a diagnosis of:

    • post-herpetic neuralgia (PHN)
    • diabetic neuropathy (DN)
    • complex regional pain syndrome (CRPS)
    • HIV neuropathy
    • idiopathic sensory neuropathy
    • traumatic peripheral neuropathy
    • central neuropathic pain condition (spinal cord injury, post-stroke pain), OR
    • other peripheral neuropathy (upon mutual agreement of the sponsor and investigator).

Exclusion Criteria:

  • Have a positive pregnancy test (females only)
  • Have a history of or active asthma or emphysema
  • Have clinically significant hepatic impairment
  • Have a history of alcohol or substance abuse within the last 3 years
  • Have a history of opioid abuse within 6 months prior to study entry
  • Have a known allergy or significant reaction to opioids, including codeine
  • Have a known oxymorphone sensitivity or allergy
  • Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911261

Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Study Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr. Director, CR&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00911261     History of Changes
Other Study ID Numbers: EN3202-029
Study First Received: May 15, 2009
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Cancer Pain
Neuropathic Pain
Extended Release
Long-Acting Opioid
Oxymorphone

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

ClinicalTrials.gov processed this record on August 21, 2014