Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain

PHASE4TerminatedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

April 24, 2015

Primary Completion Date

June 26, 2019

Study Completion Date

June 26, 2019

Conditions
Moderate-severe Pain
Interventions
DRUG

Ages 7-11

Oral/Capsule, once per day or twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 6 week Maintenance Treatment duration.

DRUG

ages 12-17

Oral/Capsule, once per day or twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 6 week Maintenance Treatment duration.

Trial Locations (19)

27834

East Carolina University Brody School of Medicine(ECU), Greenville

Leo Jenkins Cancer Center Pharmacy Attn: Rebecca Turnage, Greenville

33014

Veritas Research Corp., Miami Lakes

33136

Holtz Children Hospital/Jackson Memorial Hospital, Miami

Jackson Memorial Hospital - Pharmacy Department Basement West, Miami

Sylvester Comprehensive Cancer Center-Alex's Place, Miami

University of Miami / Jackson Memorial Hospital, Miami

33155

Nicklaus Children's Hospital, Miami

60612

University of Illinois at Chicago Clinical Research Center, Chicago

University of Illinois at the Med Center, University of Illinois, Chicago

University of Illinois Hospital and Health Sciences System, Chicago

84113

Primary Children's Hospital Outpatient Services, Salt Lake City

Primary Children's Hospital, Salt Lake City

90027

Children's Hospital Los Angeles, Los Angeles

92697

Gottschalk Medical Plaza, Irvine

92868

The University of California, Irvine Health - Medical Specialties, Orange

UCI Medical Center- Outpatient Pharmacy, Orange

University of California, Irvine Health-Inpatient Pharmacy, Orange

University of California, Irvine Health-Medical Specialties, Orange

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY