NCT00947466

A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain

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.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy Induced Mucositis
• Mouth Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine	Transdermal patch

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2009-07-28
• Last updated: 2018-10-24

Locations

2 sites across 2 countries: Denmark, United Kingdom