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

Purdue Pharma

Status and phase

Completed

Phase 3

Conditions

Pain

Treatments

Drug: Buprenorphine transdermal system

Study type

Interventional

Funder types

Industry

Identifiers

NCT01324570

BUP3031

2010-021954-21 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

41 patients

Sex

All

Ages

7 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.