Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients
 of ages 7 to 16 years.
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.
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.