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.
Purdue Pharma LP
- Drug: Hydromorphone
- 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.
- 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