Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain

Completed · Phase 3

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT00225797

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

160

Starts

2004-11-01

Expected to finish

2005-07-01

Last updated by the study team

2024-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southern Drug Research — Hueytown, Alabama, United States
• Phoenix Center for Clinical Research — Phoenix, Arizona, United States
• Express Care Clinical Research — Colorado Springs, Colorado, United States
• New England Research — Bridgeport, Connecticut, United States
• Glasgow Family Practice — Newark, Delaware, United States
• Radiant Research — Daytona Beach, Florida, United States
• University Clinical Research — DeLand, Florida, United States
• LCFP Inc — Fort Myers, Florida, United States
• Century Clinical Research — Holly Hill, Florida, United States
• Ocala Rheumatology Research Center — Ocala, Florida, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• University Clinical Research — Pembroke Pines, Florida, United States
• Radiant Research — Pinellas Park, Florida, United States
• Park Place Therapeutic Center — Plantation, Florida, United States
• ICSL Clinical Studies — St. Petersburg, Florida, United States
• Comprehensive Neurology Specialists — Atlanta, Georgia, United States
• Comprehensive Neuroscience — Atlanta, Georgia, United States
• Pain Specialists of Greater Chicago — Burr Ridge, Illinois, United States
• Mid-America Physiatrists — Overland Park, Kansas, United States
• Research Medical Center — Kansas City, Missouri, United States
• Radiant Research — St Louis, Missouri, United States
• Piedmont Anesthesia — Winston-Salem, North Carolina, United States
• Keystone Clinical Solutions — Altoona, Pennsylvania, United States
• Perkiomen Valley Family Practice — Collegeville, Pennsylvania, United States
• Feasterville Family Health Center — Feasterville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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