Status:
TERMINATED
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Chronic Pain
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosi...
Detailed Description
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
Eligibility Criteria
Inclusion
- Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
- Weigh at least 50 kg
- Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.
Exclusion
- Have a life expectancy \<4 weeks
- Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
- Have dysphagia or difficulty swallowing whole tablets
- Have a previous exposure to oxymorphone
- Have an ileostomy
Key Trial Info
Start Date :
November 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00765856
Start Date
November 17 2008
End Date
February 22 2010
Last Update
December 16 2020
Active Locations (13)
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1
Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine
Little Rock, Arkansas, United States, 72202
2
Stanford University School of Medicine
Stanford, California, United States, 94305
3
The Children's Hospital
Aurora, Colorado, United States, 80045
4
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106