A Multi-center, Open-label, Dose Titration Study Pharmacokinetics/Pharmacodynamics, Safety, and Efficacy of Hydromorphone Oral Solution in Subjects From 28 Days to 16 Years of Age, Who Require Opioid Analgesics for Postoperative Pain

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.

Stanford is now accepting new patients for this trial. Please contact Greg Hammer at 6507237835 for more information.

Investigator(s):

Intervention(s):

  • drug : Hydromorphone

Phase: Phase 4

Eligibility

Ages Eligible For Study:

N/A - 16 Years

Inclusion Criteria

- 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.

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Contact information

Primary Contact:

Greg Hammer 6507237835

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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