An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain

Completed · Phase 4

Conditions studied: Postoperative Pain

In brief

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 objectives are to characterize the safety and efficacy of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.

Key facts

Study ID

NCT00465647

Run by

Purdue Pharma LP

People needed

116

Starts

2007-04-01

Expected to finish

2010-04-01

Last updated by the study team

2015-11-18

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital of Orange County - Pediatric Subspecialty — Orange, California, United States
• Stanford University Medical Center — Stanford, California, United States
• The Children's Hospital — Aurora, Colorado, United States
• Yale-New Haven Children's Hospital — New Haven, Connecticut, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Saint Louis University - Department of Neurology and Psychiatry — St Louis, Missouri, United States
• The University of North Carolina - CH — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Children's Hospital Medical Center of Akron — Akron, Ohio, United States
• Children's Medical Center — Dallas, Texas, United States
• Texas Children's Hospital / Baylor College of Medicine — Houston, Texas, United States
• The University of Texas, Health Sciences Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.