drugset / Trial / NCT02321319
Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
NaSingle-groupOpen-labelTreatment
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydromorphone | Other / unclassified | 4 mg | — |
| Subject | Hydromorphone | Other / unclassified | 16 mg | — |