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Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain

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ClinicalTrials.gov Identifier: NCT00911287
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : February 10, 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 ER is effective and safe in treating chronic pain in opioid-naive patients.

Condition or disease Intervention/treatment Phase
Pain Chronic Disease Drug: Oxymorphone extended release Phase 3

Detailed Description:
The purpose of this study is to assess the effectiveness and tolerability of oxymorphone ER for the treatment of moderate to severe chronic pain in opioid-naive patients. Patients are gradually titrated from a 5mg dose of oxymorphone ER (taken every 12 hours) until stabilized dose is achieved. The study design is an open-label, nonrandomized 6-month study with a titration/stabilization period of ≤ 1 month followed by a 5-month maintenance period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Effectiveness and Safety Study of Oxymorphone Extended Release in Opioid-Naive Patients With Chronic Pain.
Study Start Date : June 2003
Actual Primary Completion Date : January 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets. Treatment will consist of up to 6 months of dosing with oxymorphone ER.


Outcome Measures
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Primary Outcome Measures :
  1. Tolerability. [ Time Frame: Entire study duration, including follow-up period. ]

Secondary Outcome Measures :
  1. Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period [ Time Frame: Week 1-4, Month 1-6 ]
  2. Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire [ Time Frame: Week 1-4, Month 1-6 ]
  3. Average daily dose of oxymorphone ER [ Time Frame: Entire study duration ]
  4. Rescue medication. [ Time Frame: Entire study duration ]
  5. Total daily dose of oxymorphone ER and rescue medication [ Time Frame: Entire study duration ]
  6. Time to stabilization. Patient/investigator global assessments [ Time Frame: Month 6 ]
  7. Treatment satisfaction [ Time Frame: Month 6 ]

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:

  • Currently receive a stable non-opioid analgesic regimen
  • Have an initial pain intensity score of greater than or equal to 40 mm on a 100-mm Visual Analogue Scale (VAS) and a categorical pain rating of moderate or severe on a categorical scale of none, mild, moderate, or severe
  • If female, must be practicing abstinence or using a medically acceptable form of contraception
  • Understand written and spoken English
  • Have been informed of the nature of the study and provided written informed consent.

Exclusion Criteria:

  • Positive pregnancy test (females only)
  • History of or active asthma or emphysema
  • Clinically significant hepatic impairment

  • Received any of the following medications within 48 hours prior to dosing:

    • Dextromethorphan-containing medications (over-the-counter [OTC] cough and cold preparations, such as Vicks Formula 44)
    • St. John's Wort >1000 mg/day
  • Received monoamine oxidase inhibitor (MAOI) drugs within 2 weeks prior to dosing

  • Are not stabilized on the following medications for at least 4 weeks prior to dosing:

    • Tricyclic antidepressant drugs
    • Serotonin reuptake inhibitors
    • Amphetamines used for attention-deficit/hyperactivity disorder (ADHD)
  • History of alcohol or substance abuse within the last 3 years
  • History of opioid abuse within 6 months prior to study entry
  • Have a known oxymorphone sensitivity or allergy
  • Have scheduled an elective surgery or procedure during the study that would not permit continuation of study medication, and/ or require another analgesic not currently taken by the patient
  • 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
  • Have a known allergy or significant reaction to opioids
  • Have been a participant in a previous oxymorphone clinical trial
  • Have a history of seizure (Patients with a history of juvenile febrile seizures may be included if there has been no seizure history within the past 10 years).
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): NCT00911287


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

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Responsible Party: Sr. Director, CR&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00911287    
Other Study ID Numbers: EN3202-028
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: February 2010
Keywords provided by Endo Pharmaceuticals:
Chronic pain
Extended Release
Long-Acting Opioid
 Opioid
Opioid-Naive
Oxymorphone
Additional relevant MeSH terms:
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Chronic Pain
Chronic Disease
Pain
Neurologic Manifestations
Disease Attributes
Pathologic Processes
Oxymorphone
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia