Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain
- Conditions
- Chronic Pain
- Registration Number
- NCT00226421
- Lead Sponsor
- Endo Pharmaceuticals
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in pain intensity from baseline (pre-randomization) to last assessment.
- Secondary Outcome Measures
Name Time Method - Physician's Global Assessment of Pain Medication - Pain Quality Assessment Scale - Patient's Global Assessment of Pain Medication - Safety as measured by AEs - Time to early discontinuation due to lack of efficacy
Trial Locations
- Locations (29)
Mid-America Physiatrists
🇺🇸Overland Park, Kansas, United States
Ocala Rheumatology Research Center
🇺🇸Ocala, Florida, United States
Feasterville Family Health Center
🇺🇸Feasterville, Pennsylvania, United States
Glasgow Family Practice
🇺🇸Newark, Delaware, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Pain Specialists of Greater Chicago
🇺🇸Burr Ridge, Illinois, United States
Century Clinical Research
🇺🇸Holly Hill, Florida, United States
LCFP Inc.
🇺🇸Fort Myers, Florida, United States
The Arthritis Center
🇺🇸Palm Harbor, Florida, United States
Waccamaw Pain Management
🇺🇸Murrells Inlet, South Carolina, United States
Park Place Therapeutic Center
🇺🇸Plantation, Florida, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Perkiomen Valley Family Practice
🇺🇸Collegeville, Pennsylvania, United States
Pain Consultants of Oregon
🇺🇸Eugene, Oregon, United States
Southern Drug Research
🇺🇸Hueytown, Alabama, United States
Comprehensive Neuroscience
🇺🇸Atlanta, Georgia, United States
University Clinical Research
🇺🇸DeLand, Florida, United States
Comprehensive Neurology Specialists
🇺🇸Atlanta, Georgia, United States
Express Care Clinical Research
🇺🇸Colorado Springs, Colorado, United States
Arizona Research
🇺🇸Phoenix, Arizona, United States
Phoenix Center for Clinical Research
🇺🇸Phoenix, Arizona, United States
Health Research Institute
🇺🇸Oklahoma City, Oklahoma, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Keystone Medical Research
🇺🇸Altoona, Pennsylvania, United States
KRK Medical Research
🇺🇸Richardson, Texas, United States
Paragon Clinical Research
🇺🇸Cranston, Rhode Island, United States
Piedmont Anesthesia
🇺🇸Winston-Salem, North Carolina, United States
Fleetwood Clinical Research
🇺🇸Fleetwood, Pennsylvania, United States
Radiant Research
🇺🇸Saint Louis, Missouri, United States