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

NCT ID: NCT01324570

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2016-05-31

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Overall BTDS

Buprenorphine transdermal system

Group Type: EXPERIMENTAL

Buprenorphine transdermal system

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Butrans

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Long Beach Memorial Medical Center

Long Beach, California, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Children's Health Center

Los Angeles, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Howard University Hospital

Washington D.C., District of Columbia, United States

Jackson Memorial Hospital / University of Miami

Miami, Florida, United States

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, United States

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, United States

Kosair Charities Pediatric Clinical Research Unit - University of Louisville

Louisville, Kentucky, United States

Willis-Knighton Physician Network

Shreveport, Louisiana, 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

Stony Brook University Hospital

Stony Brook, New York, United States

Children's Hospital at Montefiore

The Bronx, New York, United States

Vidant Medical Center

Greenville, North Carolina, United States

The Center for Clinical Research - Carolina Pain Institute

Winston-Salem, North Carolina, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital, Department of Pediatrics

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Children's Blood and Cancer Center

Austin, Texas, United States

Road Runner Research, Ltd.

San Antonio, Texas, United States

Countries

United States

Other Identifiers

2010-021954-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BUP3031

Identifier Type: -

Identifier Source: org_study_id