Efficacy and Safety of Oxmorphone Extended Release in 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-Naïve Patients With Chronic Low Back Pain

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with low back pain who are sub-optimally responsive to their current analgesic treatment begin open-label treatment with oxymorphone extended release (ER). During the Open-Label Titration Period, patients will receive daily oxymorphone ER by mouth (PO) q12h. The investigator will initiate the Open-Label Titration Period using study drug at a dose of 5 mg PO q12h for 2 days; thereafter, patients will continue receiving 5 mg q12h or be titrated at increments of 5-10 mg q12h every 3-7 days until stabilization is achieved. The goal of the Open-Label Titration Period is to determine for each patient a fixed dose of study medication that is tolerated and achieves adequate analgesia. Stabilized patients will be randomiozed to either continue with current dose of oxymorphone ER or receive placebo for a total duration of 12 weeks.

Study Type

Interventional

Enrollment

160

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
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Express Care Clinical Research
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • New England 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
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research
      • Plantation, Florida, United States, 33324
        • Park Place Therapeutic Center
      • Saint Petersburg, Florida, United States, 33702
        • ICSL Clinical Studies
    • 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
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Anesthesia
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Keystone Clinical Solutions
      • 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
      • Cranston, Rhode Island, United States, 02920
        • New England Center for Clinical Research
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Radiant Research
      • 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
      • Salt Lake City, Utah, United States, 84102
        • Intermountain Clinical 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
  • opioid naïve
  • Have an initial pain intensity score of at least 50 mm VAS
  • In good health as determined by the investigator on the basis of medical history and physical examination
  • Have moderate to severe chronic non-neuropathic LBP that has been present daily for at least several hours per day for a minimum of three months prior to the Screening
  • 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
  • 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, or inhalation analgesia). The patient must not have a nerve/plexus block within 4 weeks of screening
  • Intend to alter 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, or an inability to take oral medication
  • 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
  • Ileostomy or colostomy
  • 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
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

November 1, 2004

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

September 22, 2005

First Submitted That Met QC Criteria

September 22, 2005

First Posted (Estimated)

September 26, 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

  • EN3202-031

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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