Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
Stopped early · Phase 3
Conditions studied: Chronic Pain
In brief
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.
Key facts
- Study ID
- NCT02321319
- Run by
- Mallinckrodt
- People needed
- 5
- Starts
- 2017-03-11
- Expected to finish
- 2019-02-04
- Last updated by the study team
- 2020-05-21
Who can join
Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Jackson Memorial Hospital, University of Miami — Miami, Florida, United States
- Medical Professional Clinical Research — Miami, Florida, United States
- Clinical Pharmacology Services, Inc. — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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