Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
Condition: Pain
Intervention: Buprenorphine transdermal system
Intervention description: Buprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 7 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Pain; Opioid; Analgesia; Moderate to severe pain

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

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.