Phase 3
Completed N=41
Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
Source: ClinicalTrials.gov NCT01324570 ↗Enrolled (actual)
41
Serious AEs
24.4%
Results posted
Jul 2017
Primary outcomePrimary: The Number of Participants With Adverse Events as a Measure of Safety — 5; 5; 6; 20 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Adverse Events as a Measure of Safety |
5; 5; 6; 20 | — |
| PRIMARY Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F) |
293 | — |
| PRIMARY Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F) |
2350 | — |
| SECONDARY Pain Right Now Assessment by Patients Aged 7 to 11 Years, Inclusive |
2.80; 3.49; 2.98; 0.29; 0.00; 0.00 | — |
| SECONDARY Pain Right Now Assessment by Patients Aged 12 to 16 Years, Inclusive |
46.6; 43.1; 41.6; 36.0; 34.7; 30.3 | — |
| SECONDARY Parent/Caregiver-assessed Global Impression of Change (PGIC) |
4; 34; 1; 6; 0; 12 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01324570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.