A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain
- Registration Number
- NCT00947466
- Lead Sponsor
- Mundipharma Research Limited
- Brief Summary
The purpose of this study is to characterize the pharmacokinetics and tolerability of buprenorphine patches in children who require opioid pain relief for moderate to severe mouth pain.
- Detailed Description
Subjects will be screened for eligibility and if eligible will apply a buprenorphine patch (Day 1). The patch will be worn for 7 days during which time, safety assessments, pain scores, mucositis scores, PK sampling \& vital signs will be assessed on each day. After patch removal subjects will continue with these assessments on a daily basis until Day 12. The subject will then be followed up for 10 days (to Day 22) to collect information on ongoing/new SAEs/AEs.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patch Buprenorphine -
- Primary Outcome Measures
Name Time Method To characterise the pharmacokinetics of BTDS 5-20 ug/h in children weighing >15kg PK's taken daily for 12 days
- Secondary Outcome Measures
Name Time Method safety & tolerability of BTDS 5-20ug/h in children every 4 hours to day 5, day 12 and day 21
Trial Locations
- Locations (1)
Dr Howell
🇬🇧Liverpool, United Kingdom