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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324570
• Other study ID #: BUP3031
• Secondary ID: 2010-021954-21
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2011
• Last updated: October 6, 2016
• Start date: July 2011
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 16 Years

Eligibility

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 morphine or equivalent if aged 12 to 16 years or = 40 mg morphine or equivalent if aged 7 to 11 years prior to initiation with BTDS treatment;

• Patients must be able to understand and complete the age appropriate scale to rate pain intensity, ie, patients must not have a cognitive developmental delay or any other condition that would preclude them from completing age appropriate pain scale;

• Patients with malignant and/or nonmalignant medical conditions causing moderate to severe pain requiring continuous, around-the-clock opioid analgesic therapy such as cancer, sickle-cell disease (eg, resulting in persistent body pain, persistent limb pain, avascular necrosis, persistent abdominal pain), persistent orthopedic pain (eg, spinal injury, spinal disc herniation, persistent limb/stump pain, major trauma), juvenile rheumatoid arthritis (pain not controlled by therapy treating the underlying disease), and cystic fibrosis resulting in persistent chest pain;

• Patients must have a parent/caregiver who is willing and able to be compliant with the protocol, capable of patient evaluation, able to read and understand questionnaires, willing and able to use a diary, and able to read, understand, and sign the written informed consent.

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]);

• Patients who have allergies or other contraindications to transdermal delivery systems or patch adhesives;

• Patients with a dermatological disorder 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 who have a history of sleep apnea within the past year;

• Patients with unstable respiratory disease;

• Patients with structural heart disease or a pacemaker;

• Patients with clinically unstable cardiac disease;

• Patients who, in the opinion of the investigator, are unsuitable to participate in this study for any reason;

• Patients who receive or anticipate to receive investigational medication/therapy during study drug treatment period.

Other protocol-specific inclusion/exclusion criteria may apply.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Children's Blood and Cancer Center	Austin	Texas
United States	Children's Hospital at Montefiore	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Illinois Hospital and Health Sciences System	Chicago	Illinois
United States	Vidant Medical Center	Greenville	North Carolina
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Children's Health Center	Los Angeles	California
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	Kosair Charities Pediatric Clinical Research Unit - University of Louisville	Louisville	Kentucky
United States	Jackson Memorial Hospital / University of Miami	Miami	Florida
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	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital, Department of Pediatrics	Providence	Rhode Island
United States	Road Runner Research, Ltd.	San Antonio	Texas
United States	Willis-Knighton Physician Network	Shreveport	Louisiana
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Howard University Hospital	Washington	District of Columbia
United States	The Center for Clinical Research - Carolina Pain Institute	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants with adverse events as a measure of safety.		4 weeks	Yes
Primary	Pharmacokinetics of buprenorphine following transdermal administration	PK endpoints include the apparent Vd (volume of distribution) and apparent CL (systemic clearance) of buprenorphine following transdermal administration	Day 1, week 1, Day 9/10, week 2, and week 3	No
Secondary	"Pain Right Now" Score		Daily	No
Secondary	Parent/caregiver-assessed Global Impression of Change (PGIC)		Week 4	No

External Links

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