Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain

December 29, 2023 updated by: Endo Pharmaceuticals

An Open-Label Titration Followed by a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Oxymorphone Extended Release Tablets in Opioid-Experienced Patients With Chronic Low Back Pain

The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in opioid-experienced patients with chronic low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with chronic low back pain on stable opioid treatment will be converted to oxymorphone extended release (ER)and enter an open-label treatment phase.During the Open-Label Titration Period (up to 28 days), patients will receive daily oxymorphone ER PO q12h. Patients stabilized on a dose that provides adequate pain relief will be randomized to either continue on the stabilized dose of oxymorphone ER or receive placebo in a double-blind fashion for a total duration of 12 weeks.

Study Type

Interventional

Enrollment

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hueytown, Alabama, United States, 35023
        • Southern Drug Research
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Phoenix Center for Clinical Research
      • Phoenix, Arizona, United States, 85023
        • Arizona Research
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Express Care Clinical Research
    • Delaware
      • Newark, Delaware, United States, 19702
        • Glasgow Family Practice
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Radiant Research
      • DeLand, Florida, United States, 32720
        • University Clinical Research
      • Fort Myers, Florida, United States, 33907
        • LCFP Inc.
      • Holly Hill, Florida, United States, 32117
        • Century Clinical Research
      • Ocala, Florida, United States, 34474
        • Ocala Rheumatology Research Center
      • Palm Harbor, Florida, United States, 34684
        • The Arthritis Center
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research
      • Plantation, Florida, United States, 33324
        • Park Place Therapeutic Center
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Comprehensive Neurology Specialists
      • Atlanta, Georgia, United States, 30338
        • Comprehensive Neuroscience
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Pain Specialists of Greater Chicago
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Mid-America Physiatrists
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Saint Louis, Missouri, United States, 63141
        • Radiant Research
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Comprehensive Clinical Research
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Anesthesia
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Health Research Institute
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pain Consultants of Oregon
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Keystone Medical Research
      • Collegeville, Pennsylvania, United States, 19426
        • Perkiomen Valley Family Practice
      • Feasterville, Pennsylvania, United States, 19053
        • Feasterville Family Health Center
      • Fleetwood, Pennsylvania, United States, 19522
        • Fleetwood Clinical Research
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Paragon Clinical Research
    • South Carolina
      • Murrells Inlet, South Carolina, United States, 29576
        • Waccamaw Pain Management
    • Texas
      • Richardson, Texas, United States, 75080
        • KRK Medical Research
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males or females 18 years of age or older
  • In good health as determined by the Investigator on the basis of medical history and physical examination.
  • Moderate to severe chronic non-neuropathic low back pain that has been present daily for at least several hours per day for a minimum of three months prior to the screening.
  • On a stable around-the-clock opioid pain medication for the management of moderate to severe chronic lower back pain.
  • Expected to require a total daily oxymorphone ER dose that is a minimum of 20 mg per day (oral morphine equivalent: approximately 60 mg) and will not exceed 220 mg oxymorphone ER (oral morphine requirement: approximately 660 mg).
  • Any adjunct therapy for back pain such as physical therapy, biofeedback therapy, acupuncture therapy or herbal remedies, based on the patient's current status should remain unchanged during the period of participation of the patient.
  • Written informed consent

Exclusion Criteria:

  • Pregnant and/or lactating
  • Subjects with radiculopathy, fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, severe lower extremity weakness or numbness, bowel or bladder dysfunction secondary to cauda equina compression, diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection or tumor.
  • Cannot or will not agree to stop local regional pain treatments during the study (nerve/plexus blocks or ablation, neurosurgical procedures for pain control, Botulinum toxin injections, or inhalation analgesia). The patient must not have a nerve/plexus block within 4 weeks of screening (Visit 1). The patient must not have a Botulinum toxin injection in the lower back region within 3 months of screening.
  • Intend to alter their physical therapy regimen during the study.
  • Surgical procedures directed towards the source of back pain within 6 months of screening.
  • Pain which is secondary to confirmed or suspected neoplasm.
  • Dysphagia or difficulty swallowing tablets or capsules.
  • Significant prior history of substance abuse or alcohol abuse.
  • Use of any investigational medication within 30 days prior to the first dose of study medication.
  • Previous exposure to oxymorphone.
  • History of clinically significant intolerance to oxymorphone or a known hypersensitivity to opioid analgesics.
  • History of seizure.
  • use of MAO inhibitor within 14 days prior to the start of study medication.
  • Other clinically significant conditions as judged by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in pain intensity from baseline (pre-randomization) to last assessment.

Secondary Outcome Measures

Outcome Measure
- Time to early discontinuation due to lack of efficacy
- Patient's Global Assessment of Pain Medication
- Physician's Global Assessment of Pain Medication
- Pain Quality Assessment Scale
- Safety as measured by AEs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 23, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (Estimated)

September 27, 2005

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN3202-032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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