Clinical trial NCT01324570: Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Pain
Opioid
Analgesia
Moderate to severe pain
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 41
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria include:

* 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.

Exclusion Criteria include:

* 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.

Other protocol-specific inclusion/exclusion criteria may apply.

Primary outcomes:
measure: The Number of Participants With Adverse Events as a Measure of Safety
timeFrame: Up to 28 weeks
measure: Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F)
timeFrame: 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
measure: Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F)
timeFrame: 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:
measure: Pain Right Now Assessment by Patients Aged 7 to 11 Years, Inclusive
timeFrame: Up to 24 weeks
measure: Pain Right Now Assessment by Patients Aged 12 to 16 Years, Inclusive
timeFrame: Up to 24 weeks
measure: Parent/Caregiver-assessed Global Impression of Change (PGIC)
timeFrame: End of treatment (week 24) or early discontinuation visit
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Los Angeles
country: United States
facility: Children's Health Center
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Washington, D.C.
country: United States
facility: Howard University Hospital
state: District of Columbia
city: Miami
country: United States
facility: Jackson Memorial Hospital / University of Miami
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System
state: Illinois
city: Louisville
country: United States
facility: Kosair Charities Pediatric Clinical Research Unit - University of Louisville
state: Kentucky
city: Shreveport
country: United States
facility: Willis-Knighton Physician Network
state: Louisiana
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: New York
country: United States
facility: WCMC, Department of Pediatrics - Hematology/Oncology
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: The Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research - Carolina Pain Institute
state: North Carolina
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital, Department of Pediatrics
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Children's Blood and Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd.
state: Texas
Study officials:
References: