Last updated on February 2018

Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients


Brief description of study

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.

Clinical Study Identifier: NCT02321319

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