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

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.

Timeline

Start

2017-03-11

Primary completion

2019-02-04

Completion

2019-02-04

Outcome

Outcome not reported

Stopped (Business): “Business decision - product discontinued”

Drugs

Indications