Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
Status:
Terminated
Trial end date:
2019-02-04
Target enrollment:
Participant gender:
Summary
This pediatric study is designed to provide safety information, dosing guidelines, and a
pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl)
extended-release (ER) tablets in children with chronic painful conditions who are
"opioid-tolerant" prior to enrollment under the Pediatric Research Equity Act (PREA) of 2003.