Hematology

An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects with Chronic Pain (IRB# 28859)

Status: Active

 

Investigators:

  • Andrew Freiberg, M.D.

 

Description:

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.

 

Eligibility:

  • 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

 

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

  • 4 Months

 

Locations:

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

 

Contacts:

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

717-531-5656

 

Categories:

  • Hematology
  • Chronic Pain