A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain (BUP1501)
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.
Chemotherapy Induced Mucositis
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi Centre Open Label Single Therapy Dose Ranging Study to Characterise the Pharmacokinetics & Tolerability of BTDS 5-20 ug/h in Children Who Require Opioid Analgesia for Moderate to Severe Mouth Pain Secondary to Chemotherapy Induced Mucositis.|
- To characterise the pharmacokinetics of BTDS 5-20 ug/h in children weighing >15kg [ Time Frame: PK's taken daily for 12 days ] [ Designated as safety issue: No ]
- safety & tolerability of BTDS 5-20ug/h in children [ Time Frame: every 4 hours to day 5, day 12 and day 21 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947466
|Liverpool, United Kingdom|