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

NCT00947466 | Terminated Phase 1 DMC

• 2 other identifiers: BUP15012008-002428-27
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 2

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.

Conditions

Chemotherapy Induced Mucositis; Mouth Pain

Keywords

Buprenorphine transdermal patch (BTDS); Moderate to severe mouth pain; Chemotherapy induced mucositis; Pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• To characterise the pharmacokinetics of BTDS 5-20 ug/h in children weighing >15kg

  PK's taken daily for 12 days

Secondary Outcomes (1)

• safety & tolerability of BTDS 5-20ug/h in children

  every 4 hours to day 5, day 12 and day 21

Study Arms (1)

Patch

EXPERIMENTAL

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

Transdermal patch

Patch

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• Subjects experiencing 'severe' pain in the Investigators clinical judgment.
• 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.
• In dwelling IV cannula or central line from which blood can be obtained.
• Written informed consent obtained from parent(s)/legal representative, and where possible assent obtained from the subject if appropriate, in line with local regulations.
• 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.

You may not qualify if:

• 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.
• Known hypersensitivity to other opioids.
• Skin disease affecting application or local tolerance of BTDS.
• Clinically significant history of allergic reaction to wound dressings or adhesives.
• Severe respiratory impairment.
• Clinically significant hepatic dysfunction.
• Severe renal impairment.
• Subjects who are receiving MAO inhibitors or have taken them within the previous 2 weeks.
• 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.
• Subjects who have taken any buprenorphine preparations in the last 14 days.
• Subjects with myasthenia gravis.
• Subjects with convulsive disorders, head injury, shock, or reduced level of consciousness of uncertain origin.
• Subjects who are pregnant, lactating or in the Investigators opinion are at risk of conceiving.
• Previous enrollment in this clinical study.
• Subjects who the Investigator believes are unsuitable for the study.

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (2)

Unknown Facility

Skejby, Denmark

Location

Dr Howell

Liverpool, United Kingdom

Location

Related Links

• Results available onw ebsite

MeSH Terms

Interventions

Buprenorphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 28, 2009
• Study Start: February 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

GB (1); DK (1)