Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain
Chronic Pain
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring opioid, oxymorphone, chronic pain, randomized, double-blind trial, low back pain
Eligibility Criteria
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.
Sites / Locations
- Southern Drug Research
- Phoenix Center for Clinical Research
- Arizona Research
- Express Care Clinical Research
- Glasgow Family Practice
- Radiant Research
- University Clinical Research
- LCFP Inc.
- Century Clinical Research
- Ocala Rheumatology Research Center
- The Arthritis Center
- Radiant Research
- Park Place Therapeutic Center
- Comprehensive Neurology Specialists
- Comprehensive Neuroscience
- Pain Specialists of Greater Chicago
- Mid-America Physiatrists
- Research Medical Center
- Radiant Research
- Comprehensive Clinical Research
- Piedmont Anesthesia
- Health Research Institute
- Pain Consultants of Oregon
- Keystone Medical Research
- Perkiomen Valley Family Practice
- Feasterville Family Health Center
- Fleetwood Clinical Research
- Paragon Clinical Research
- Waccamaw Pain Management
- KRK Medical Research
- Jean Brown Research