Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain
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
1 other identifier
interventional
120
1 country
31
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 chronic-pain
Started Oct 2004
Shorter than P25 for phase_3 chronic-pain
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 23, 2005
CompletedFirst Posted
Study publicly available on registry
September 27, 2005
CompletedJanuary 2, 2024
December 1, 2023
September 23, 2005
December 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pain intensity from baseline (pre-randomization) to last assessment.
Secondary Outcomes (5)
- 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Southern Drug Research
Hueytown, Alabama, 35023, United States
Phoenix Center for Clinical Research
Phoenix, Arizona, 85015, United States
Arizona Research
Phoenix, Arizona, 85023, United States
Express Care Clinical Research
Colorado Springs, Colorado, 80909, United States
Glasgow Family Practice
Newark, Delaware, 19702, United States
Radiant Research
Daytona Beach, Florida, 32114, United States
University Clinical Research
DeLand, Florida, 32720, United States
LCFP Inc.
Fort Myers, Florida, 33907, United States
Century Clinical Research
Holly Hill, Florida, 32117, United States
Ocala Rheumatology Research Center
Ocala, Florida, 34474, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
Radiant Research
Pinellas Park, Florida, 33781, United States
Park Place Therapeutic Center
Plantation, Florida, 33324, United States
Comprehensive Neurology Specialists
Atlanta, Georgia, 30338, United States
Comprehensive Neuroscience
Atlanta, Georgia, 30338, United States
Pain Specialists of Greater Chicago
Burr Ridge, Illinois, 60527, United States
Mid-America Physiatrists
Overland Park, Kansas, 66211, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Radiant Research
St Louis, Missouri, 63141, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Piedmont Anesthesia
Winston-Salem, North Carolina, 27103, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
Pain Consultants of Oregon
Eugene, Oregon, 97401, United States
Keystone Medical Research
Altoona, Pennsylvania, 16602, United States
Perkiomen Valley Family Practice
Collegeville, Pennsylvania, 19426, United States
Feasterville Family Health Center
Feasterville, Pennsylvania, 19053, United States
Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522, United States
Paragon Clinical Research
Cranston, Rhode Island, 02920, United States
Waccamaw Pain Management
Murrells Inlet, South Carolina, 29576, United States
KRK Medical Research
Richardson, Texas, 75080, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Related Publications (2)
Peniston JH, Hu X, Potts SL, Wieman MS, Turk DC. Tolerability of concomitant use of selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors and oxymorphone extended release. Postgrad Med. 2012 Mar;124(2):114-22. doi: 10.3810/pgm.2012.03.2542.
PMID: 22437221DERIVEDPeniston JH, Xiang Q, Gould EM. Factors affecting acceptability of titrated oxymorphone extended release in chronic low back pain - an individual patient analysis. Curr Med Res Opin. 2010 Aug;26(8):1861-71. doi: 10.1185/03007995.2010.490457.
PMID: 20521870DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 23, 2005
First Posted
September 27, 2005
Study Start
October 1, 2004
Study Completion
August 1, 2005
Last Updated
January 2, 2024
Record last verified: 2023-12