An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects with Chronic Pain (IRB# 28859)
The primary objective of the study is to assess the safety and effectiveness of oxymorphone ER tablets in the opioid-tolerant children for treatment of chronic pain of malignant or nonmalignant etiology.
- Ages 6-17
- Chronic cancer or non-cancer pain
- Currently treated with a strong opioid for at least 5 days that will continue for at least 1-4 months
- Can swallow whole tablets
- Weigh at least 50 kg
- Can complete pain assessment evaluations
- Have given assent and have parental consent.
- Known allergy to oxymorphone or another opioid
- Life expectancy <4 weeks
- Pregnant and/or lactating
- Plan to undergo surgical procedure within 3 days of study entry or during Titration period
- Substance or alcohol abuse
- Involved in another clinical trial 30 days prior to first dose of study drug
- Previous exposure to study drug
- Unable to comply with protocol
Additional Study Details:
What is expected of me and my child?
Screening (visit 1): medical and surgical history, medication history, physical exam, weight, height, vital signs, pregnancy test, baseline pain assessment, patient diary overview, performance status. Titration Period (visits 2-4): subjects will receive daily oxymorphone ER by mouth every 12 hours, patient diary logs, play performance scale, pain assessment. Maintenance Period (visits 5-10): vital signs measures, daily oxymorphone ER by mouth every 12 hours, patient diary logs, play performance scale, pain assessment, pregnancy test (visit 5,7, & 9). End of study (Visit 11): physical exam, vital signs, patient diary logs, pregnancy test, play performance scales and pain assessment.
Length of Study
- Penn State Hershey Children's Hospital, General Clinical Research Center