Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain (NCT00225797) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain
United States160 participantsStarted 2004-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sourc…
What they're measuring
1
Change in pain intensity from baseline (pre-randomization) to last assessment.