Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children

PHASE3CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions
Pain
Interventions
DRUG

Buprenorphine transdermal system

Buprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.

Trial Locations (22)

10065

WCMC, Department of Pediatrics - Hematology/Oncology, New York

10467

Children's Hospital at Montefiore, The Bronx

11794

Stony Brook University Hospital, Stony Brook

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

20060

Howard University Hospital, Washington D.C.

27103

The Center for Clinical Research - Carolina Pain Institute, Winston-Salem

27834

Vidant Medical Center, Greenville

29425

Medical University of South Carolina, Charleston

30322

Children's Healthcare of Atlanta at Egleston, Atlanta

33136

Jackson Memorial Hospital / University of Miami, Miami

40202

Kosair Charities Pediatric Clinical Research Unit - University of Louisville, Louisville

60612

University of Illinois Hospital and Health Sciences System, Chicago

71118

Willis-Knighton Physician Network, Shreveport

78258

Road Runner Research, Ltd., San Antonio

78723

Children's Blood and Cancer Center, Austin

80045

Children's Hospital Colorado, Aurora

90027

Children's Hospital of Los Angeles, Los Angeles

90806

Long Beach Memorial Medical Center, Long Beach

90095-1752

Children's Health Center, Los Angeles

06106

Connecticut Children's Medical Center, Hartford

08901

Saint Peter's University Hospital, New Brunswick

02903

Rhode Island Hospital, Department of Pediatrics, Providence

All Listed Sponsors
lead

Purdue Pharma LP

INDUSTRY

NCT01324570 - Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children | Biotech Hunter | Biotech Hunter