A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain (BUP1501)

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.

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.

Study Overview

• Status: Terminated
• Conditions: Chemotherapy Induced Mucositis; Mouth Pain
• Intervention / Treatment: Drug: Buprenorphine

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Skejby, Denmark
• United Kingdom
  • Liverpool, United Kingdom
    • Dr Howell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Male or female children experiencing severe mouth pain secondary to chemotherapy induced mucositis requiring opioid analgesic therapy and who will be an inpatient, as a minimum up to Day 8 (patch removal).
2. Subjects experiencing 'severe' pain in the Investigators clinical judgment.
3. Body weight ≥ 15 kg. Subjects weighing ≥ 25 kg will be recruited in the first phase of the study with those weighing < 25 kg also being included in the second phase, (after a successful review by an IDSMC). Upper age range to be 16 years.
4. In dwelling IV cannula or central line from which blood can be obtained.
5. Written informed consent obtained from parent(s)/legal representative, and where possible assent obtained from the subject if appropriate, in line with local regulations.
6. Females of child bearing potential must have a negative urine pregnancy test if the Principal Investigator considers there to be a reasonable possibility of pregnancy.

Exclusion criteria:

1. Subjects with known hypersensitivity to buprenorphine or any of its excipients in the transdermal system, as outlined in the Summary of Product Characteristics for BuTrans.
2. Known hypersensitivity to other opioids.
3. Skin disease affecting application or local tolerance of BTDS.
4. Clinically significant history of allergic reaction to wound dressings or adhesives.
5. Severe respiratory impairment.
6. Clinically significant hepatic dysfunction.
7. Severe renal impairment.
8. Subjects who are receiving MAO inhibitors or have taken them within the previous 2 weeks.
9. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator's opinion, may pose a risk of additional CNS depression with study medication.
10. Subjects who have taken any buprenorphine preparations in the last 14 days.
11. Subjects with myasthenia gravis.
12. Subjects with convulsive disorders, head injury, shock, or reduced level of consciousness of uncertain origin.
13. Subjects who are currently participating in another clinical research study involving a new chemical entity (NCE) unless the sole purpose of the other trial at the time of BUP1501 screening is for long term follow-up/survival data or subjects who have participated in a clinical study within the previous 30 days. Participation in a chemotherapy clinical trial that is not evaluating a NCE will be accepted for inclusion.
14. Subjects who are pregnant, lactating or in the Investigators opinion are at risk of conceiving.
15. Previous enrollment in this clinical study.
16. Subjects who the Investigator believes are unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patch	Drug: Buprenorphine; Transdermal patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To characterise the pharmacokinetics of BTDS 5-20 ug/h in children weighing >15kg	PK's taken daily for 12 days

Secondary Outcome Measures

Outcome Measure	Time Frame
safety & tolerability of BTDS 5-20ug/h in children	every 4 hours to day 5, day 12 and day 21

Collaborators and Investigators

• Sponsor: Mundipharma Research Limited

Publications and helpful links

Helpful Links

• Results available onw ebsite

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 27, 2009
• First Posted (Estimate): July 28, 2009

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacokinetic; Buprenorphine transdermal patch (BTDS); Moderate to severe mouth pain; Chemotherapy induced mucositis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: BUP1501; 2008-002428-27