Trial Search Results

An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years 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 currently not accepting patients for this trial.

Lead Sponsor:

Purdue Pharma LP

Stanford Investigator(s):

Intervention(s):

  • Drug: Hydromorphone

Phase:

Phase 4

Eligibility


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.

Exclusion Criteria:

   - 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.

Ages Eligible for Study

N/A - 16 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Greg Hammer
6507237835
Recruiting