Clinical trial NCT00226421 (phase 3, status: completed)
Conditions: chronic pain
ICD codes: G89.29, G89.4, R39.82, G89.22, G89.28, G89.21, G89.3
Drugs: oxymorphone extended release
SMILES: [H][C@@]12OC3=C(O)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1(O)CCC2=O
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.