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

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00911287
First received: May 15, 2009
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

The purpose of this study is to determine if oxymorphone ER is effective and safe in treating chronic pain in opioid-naive patients.


Condition Intervention Phase
Pain
Chronic Disease
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 Effectiveness and Safety Study of Oxymorphone Extended Release in Opioid-Naive Patients With Chronic Pain.

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Tolerability. [ Time Frame: Entire study duration, including follow-up period. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire [ Time Frame: Week 1-4, Month 1-6 ] [ Designated as safety issue: No ]
  • Average daily dose of oxymorphone ER [ Time Frame: Entire study duration ] [ Designated as safety issue: No ]
  • Rescue medication. [ Time Frame: Entire study duration ] [ Designated as safety issue: No ]
  • Total daily dose of oxymorphone ER and rescue medication [ Time Frame: Entire study duration ] [ Designated as safety issue: No ]
  • Time to stabilization. Patient/investigator global assessments [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Treatment satisfaction [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: June 2003
Study Completion Date: March 2004
Primary Completion Date: January 2004 (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, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets. Treatment will consist of up to 6 months of dosing with oxymorphone ER.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00911287

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

Publications:
Responsible Party: Sr. Director, CR&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00911287     History of Changes
Other Study ID Numbers: EN3202-028
Study First Received: May 15, 2009
Last Updated: February 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Chronic pain
Extended Release
Long-Acting Opioid
Opioid
Opioid-Naive
Oxymorphone

Additional relevant MeSH terms:
Chronic Disease
Chronic Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System 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 26, 2014