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

PHASE3TerminatedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

March 11, 2017

Primary Completion Date

February 4, 2019

Study Completion Date

February 4, 2019

Conditions
Chronic Pain
Interventions
DRUG

Hydromorphone HCl ER Tablets

Hydromorphone hydrochloride (HCl) extended release tablet

Trial Locations (3)

33136

Jackson Memorial Hospital, University of Miami, Miami

33165

Medical Professional Clinical Research, Miami

33617

Clinical Pharmacology Services, Inc., Tampa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY