Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Purdue Pharma LP
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.
Age
7–16
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
