Status:
COMPLETED
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Postoperative Pain
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity...
Eligibility Criteria
Inclusion
- Male or female \> 12 to 17 years of age, inclusive
- Weigh at least 50 kg
- Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
- Are expected to be hospitalized for the duration of the study
Exclusion
- Known allergy to, or a significant reaction to, oxymorphone or another opioid
- Life expectancy of \< 4 weeks
- Positive pregnancy test at screening
Key Trial Info
Start Date :
February 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2011
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00801398
Start Date
February 17 2009
End Date
April 18 2011
Last Update
February 27 2019
Active Locations (11)
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1
Arkansas Children's Hospital
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
Children's Research Institute
Washington D.C., District of Columbia, United States, 20010