Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
Public ClinicalTrials.gov record NCT01324570. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of Buprenorphine Transdermal System (BTDS) in Children From 7 to 16 Years of Age, Inclusive, Who Require Continuous Opioid Analgesia for Moderate to Severe Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.
Study identification
- NCT ID
- NCT01324570
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 41 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2011
- Primary completion
- Apr 30, 2016
- Completion
- Apr 30, 2016
- Last update posted
- Jul 5, 2017
2011 – 2016
United States locations
- U.S. sites
- 22
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | — |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| Children's Health Center | Los Angeles | California | 90095-1752 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Howard University Hospital | Washington D.C. | District of Columbia | 20060 | — |
| Jackson Memorial Hospital / University of Miami | Miami | Florida | 33136 | — |
| Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia | 30322 | — |
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | 60612 | — |
| Kosair Charities Pediatric Clinical Research Unit - University of Louisville | Louisville | Kentucky | 40202 | — |
| Willis-Knighton Physician Network | Shreveport | Louisiana | 71118 | — |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | — |
| WCMC, Department of Pediatrics - Hematology/Oncology | New York | New York | 10065 | — |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | — |
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | — |
| Vidant Medical Center | Greenville | North Carolina | 27834 | — |
| The Center for Clinical Research - Carolina Pain Institute | Winston-Salem | North Carolina | 27103 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Rhode Island Hospital, Department of Pediatrics | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Children's Blood and Cancer Center | Austin | Texas | 78723 | — |
| Road Runner Research, Ltd. | San Antonio | Texas | 78258 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01324570, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 5, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01324570 live on ClinicalTrials.gov.