Status:
COMPLETED
An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
Lead Sponsor:
Purdue Pharma LP
Conditions:
Postoperative Pain
Eligibility:
All Genders
28-16 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive. The secondary ...
Detailed Description
Hydromorphone is an opioid analgesic that has been used for decades as an alternative to morphine in the treatment of moderate to severe malignant and nonmalignant pain. Only a small number of analges...
Eligibility Criteria
Inclusion
- Pediatric subjects aged 28 days to 16 years,
- Prospective subjects anticipated to have postoperative pain requiring oral opioid analgesics for at least 24 hours (up to 48 hours) following postoperative parenteral analgesia (up to 48 hours),
- Prospective subjects have received no more than a total of 7 doses of opioids in the 30 days prior to surgery.
Exclusion
- Prospective subjects with clinically significant hepatic or renal dysfunction and impaired cardiac and/or respiratory reserve,
- Prospective subjects who have received opioid analgesic therapy other than hydromorphone or morphine sulfate during the up to 48-hour postoperative period prior to administration of first dose of oral hydromorphone,
- Prospective subjects who have received regional anesthetic blockade OR analgesic treatment with nonopioid medication within 6 hours prior to administration of first dose of oral hydromorphone.
- Other protocol-specific inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00465647
Start Date
April 1 2007
End Date
April 1 2010
Last Update
November 18 2015
Active Locations (14)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Children's Hospital of Orange County - Pediatric Subspecialty
Orange, California, United States, 92868
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
The Children's Hospital
Aurora, Colorado, United States, 80218