Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
- Registration Number
- NCT01324570
- Lead Sponsor
- Purdue Pharma LP
- 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.
- Detailed Description
A study of safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years, inclusive, who require continuous opioid analgesia for moderate to severe pain.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Overall BTDS Buprenorphine transdermal system Buprenorphine transdermal system
- Primary Outcome Measures
Name Time Method The Number of Participants With Adverse Events as a Measure of Safety Up to 28 weeks 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.
Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F) 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 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.
Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F) 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 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.
- Secondary Outcome Measures
Name Time Method Parent/Caregiver-assessed Global Impression of Change (PGIC) End of treatment (week 24) or early discontinuation visit The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The PGIC score was summarized using the number and percent of patients in each of the 7 possible response categories overall and by age group. PGIC was assessed by the parent/caregiver at the end of treatment visit or early discontinuation visit.
Pain Right Now Assessment by Patients Aged 7 to 11 Years, Inclusive Up to 24 weeks Pain right now was assessed using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with "no hurt" at the far left and "hurts worst" at the far right; the intensities are scored as 0, 2, 4, 6, 8, or 10. A score of 0=no pain, and 10=very much pain. For screening to week 4, pain right now was assessed at 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline score was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.
The study measured pain right now for weeks 6-24 once a week at approximately 8 PM while on treatment; however, no patients in this age group were treated beyond week 12.Pain Right Now Assessment by Patients Aged 12 to 16 Years, Inclusive Up to 24 weeks Pain right now was assessed using a 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked as "no pain" and the other marked as "pain as bad as it could be." The patient was asked to make a mark on that line indicating his or her level of pain. Pain right now score was defined as the distance (in mm) from the "no pain" end to the patient's mark; 0=no pain and bigger numbers indicate more pain. For screening to week 4, pain right now was assessed 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.
For weeks 6-24, pain right now was measured once a week at approximately 8 PM.
Trial Locations
- Locations (22)
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
Willis-Knighton Physician Network
🇺🇸Shreveport, Louisiana, United States
Howard University Hospital
🇺🇸Washington, D.C., District of Columbia, United States
University of Illinois Hospital and Health Sciences System
🇺🇸Chicago, Illinois, United States
The Center for Clinical Research - Carolina Pain Institute
🇺🇸Winston-Salem, North Carolina, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Vidant Medical Center
🇺🇸Greenville, North Carolina, United States
Children's Hospital at Montefiore
🇺🇸The Bronx, New York, United States
Children's Healthcare of Atlanta at Egleston
🇺🇸Atlanta, Georgia, United States
Rhode Island Hospital, Department of Pediatrics
🇺🇸Providence, Rhode Island, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Kosair Charities Pediatric Clinical Research Unit - University of Louisville
🇺🇸Louisville, Kentucky, United States
Children's Blood and Cancer Center
🇺🇸Austin, Texas, United States
Jackson Memorial Hospital / University of Miami
🇺🇸Miami, Florida, United States
Road Runner Research, Ltd.
🇺🇸San Antonio, Texas, United States
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
Children's Health Center
🇺🇸Los Angeles, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
WCMC, Department of Pediatrics - Hematology/Oncology
🇺🇸New York, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States