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Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00911261
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Endo Pharmaceuticals

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Pain Neuropathic Pain Cancer Drug: Oxymorphone Extended Release Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2003
Actual Primary Completion Date : March 2005
Actual Study Completion Date : May 2005

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Tolerability [ Time Frame: Throughout the study ]

Secondary Outcome Measures :
  1. Average daily pain intensity (Question 5 of BPI) [ Time Frame: Week 1-4, Month 12 ]
  2. Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire [ Time Frame: Week 1-4, Month 12 ]
  3. Average daily dose of oxymorphone ER [ Time Frame: Daily ]
  4. Average daily dose of rescue medication [ Time Frame: Daily ]
  5. Total daily dose of oxymorphone ER and rescue medication [ Time Frame: Daily ]
  6. Time to stabilization [ Time Frame: Month 12 ]
  7. Patient/investigator global assessment of pain relief [ Time Frame: Month 12 ]
  8. Treatment Satisfaction [ Time Frame: Month 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911261


Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Study Director Endo Pharmaceuticals
More Information
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Responsible Party: Sr. Director, CR&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00911261    
Other Study ID Numbers: EN3202-029
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010
Keywords provided by Endo Pharmaceuticals:
Cancer Pain
Neuropathic Pain
Extended Release
Long-Acting Opioid
Oxymorphone
Additional relevant MeSH terms:
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Neuralgia
Chronic Pain
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Oxymorphone
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia