Hematology

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.

Exclusion Criteria    

• 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
• Dysphagia
• 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

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

• 4 Months

• Penn State Hershey Children's Hospital, General Clinical Research Center

Jennifer Stokes, RN, BSN, CCRC
jstokes1@hmc.psu.edu

717-531-5656