Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
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
2 other identifiers
interventional
41
1 country
22
Brief Summary
The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pain
Started Jul 2011
Longer than P75 for phase_3 pain
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 29, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
July 6, 2017
CompletedJuly 6, 2017
June 1, 2017
4.8 years
March 24, 2011
March 10, 2017
June 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The Number of Participants With Adverse Events as a Measure of Safety
Safety assessments consisted of reports of AEs, vital signs (blood pressure, pulse rate, respiratory rate, and temperature), weight, hemoglobin-oxygen saturation measured by pulse oximetry (SpO2), clinical laboratory tests, somnolence (assessed by the University of Michigan Sedation Scale \[UMSS\]), conventional 12-lead electrocardiograms (ECGs), and 24-hour digital 12-lead ECGs (Holter monitor). Safety variables were summarized descriptively within age group for the safety population.
Up to 28 weeks
Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F)
The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the CL/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.
Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit
Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F)
The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the Vc/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.
Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit
Secondary Outcomes (3)
Pain Right Now Assessment by Patients Aged 7 to 11 Years, Inclusive
Up to 24 weeks
Pain Right Now Assessment by Patients Aged 12 to 16 Years, Inclusive
Up to 24 weeks
Parent/Caregiver-assessed Global Impression of Change (PGIC)
End of treatment (week 24) or early discontinuation visit
Study Arms (1)
Overall BTDS
EXPERIMENTALBuprenorphine transdermal system
Interventions
Buprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.
Eligibility Criteria
You may qualify if:
- Male and female patients, 7 to 16 years of age, inclusive, with malignant and/or nonmalignant moderate to severe pain requiring or anticipated to require continuous, around-the-clock, opioid treatment for at least 2 weeks (based on the investigator's judgment);
- Patients must have written informed consent provided by the parent or legal guardian and assent provided by the patient, when appropriate;
- Patients on incoming opioids must be taking ≤ 80 mg/day morphine or equivalent if aged 12 to 16 years or ≤ 40 mg/day morphine or equivalent if aged 7 to 11 years prior to the screening visit;
- Patients and patient's parent/caregiver must be compliant with the protocol, ie, must be able to perform study assessments and understand and complete the age-appropriate scale to rate pain intensity. Patients must not have a cognitive developmental delay or any other condition that would preclude them from completing the age-appropriate pain scale.
You may not qualify if:
- Patients who are allergic to buprenorphine or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects \[eg, nausea, constipation\]) or who have allergies or other contraindications to transdermal delivery systems or patch adhesives;
- Patients with a dermatological disorder, including burn and skin graft sites, at any relevant patch application site that would preclude proper placement and/or rotation of BTDS patches;
- Patients with evidence of impaired renal function;
- Patients with hepatic impairment;
- Patients with history of seizures;
- Patients with intracranial pressure;
- Patients who have a history of sleep apnea within the past year;
- Patients who require mechanical ventilation during study treatment period, are cyanotic, or who have unstable respiratory disease;
- Patients with clinically significant structural heart disease or a pacemaker;
- Patients with clinically unstable cardiac disease;
- Patients who receive or anticipate to receive investigational medication/therapy during study drug treatment period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (22)
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Children's Health Center
Los Angeles, California, 90095-1752, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Howard University Hospital
Washington D.C., District of Columbia, 20060, United States
Jackson Memorial Hospital / University of Miami
Miami, Florida, 33136, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612, United States
Kosair Charities Pediatric Clinical Research Unit - University of Louisville
Louisville, Kentucky, 40202, United States
Willis-Knighton Physician Network
Shreveport, Louisiana, 71118, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
WCMC, Department of Pediatrics - Hematology/Oncology
New York, New York, 10065, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Vidant Medical Center
Greenville, North Carolina, 27834, United States
The Center for Clinical Research - Carolina Pain Institute
Winston-Salem, North Carolina, 27103, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital, Department of Pediatrics
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Children's Blood and Cancer Center
Austin, Texas, 78723, United States
Road Runner Research, Ltd.
San Antonio, Texas, 78258, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Patient recruitment in the younger age group was difficult and the sample size is smaller than the older age group. This limitation should be a consideration when interpreting the data.
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Purdue Pharma L.P.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2011
First Posted
March 29, 2011
Study Start
July 1, 2011
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
July 6, 2017
Results First Posted
July 6, 2017
Record last verified: 2017-06