The purpose of this study is to determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.
The purpose of this study is to evaluate the analgesic effectiveness and tolerability of oxymorphone ER in the treatment of cancer or neuropathic pain. Opioid-naïve subjects are gradually titrated from oxymorphone ER 5 mg, every 12 hours (q12h). All other subjects are titrated to a stable dose (defined as pain scores ≥ 4 on BPI Question 5 on 3 of 5 consecutive days while receiving the same total daily dose of study medication including rescue) with tolerable side effects. Subjects could potentially receive therapy for up to 12 months after the first dose of study medication.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
223
* Study Medication: Oxymorphone ER 5 mg, 10 mg, 20 mg, and 40 mg tablets * Rescue Medication: Oxymorphone IR 5 mg and 10 mg tablets * Treatment will consist of up to 12 months of dosing with Oxymorphone ER.
Tolerability
Time frame: Throughout the study
Average daily pain intensity (Question 5 of BPI)
Time frame: Week 1-4, Month 12
Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire
Time frame: Week 1-4, Month 12
Average daily dose of oxymorphone ER
Time frame: Daily
Average daily dose of rescue medication
Time frame: Daily
Total daily dose of oxymorphone ER and rescue medication
Time frame: Daily
Time to stabilization
Time frame: Month 12
Patient/investigator global assessment of pain relief
Time frame: Month 12
Treatment Satisfaction
Time frame: Month 12
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