The purpose of this study is to determine if oxymorphone ER is effective and safe in treating chronic pain in opioid-naive patients.
The purpose of this study is to assess the effectiveness and tolerability of oxymorphone ER for the treatment of moderate to severe chronic pain in opioid-naive patients. Patients are gradually titrated from a 5mg dose of oxymorphone ER (taken every 12 hours) until stabilized dose is achieved. The study design is an open-label, nonrandomized 6-month study with a titration/stabilization period of ≤ 1 month followed by a 5-month maintenance period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Study Medication: Oxymorphone ER 5 mg, 10 mg, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets. Treatment will consist of up to 6 months of dosing with oxymorphone ER.
Tolerability.
Time frame: Entire study duration, including follow-up period.
Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period
Time frame: Week 1-4, Month 1-6
Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire
Time frame: Week 1-4, Month 1-6
Average daily dose of oxymorphone ER
Time frame: Entire study duration
Rescue medication.
Time frame: Entire study duration
Total daily dose of oxymorphone ER and rescue medication
Time frame: Entire study duration
Time to stabilization. Patient/investigator global assessments
Time frame: Month 6
Treatment satisfaction
Time frame: Month 6
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