NCT00947466

TerminatedPhase 1/2

A Study to Characterize the Pharmacokinetics and Tolerabilit...

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.

Mundipharma Research Limited ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

BUP1501

Secondary identifiers

2008-002428-27

2008

NIH

Study Type

interventional

Actual enrollment (reported)

25

Locations

2 countries

Sites

2

Timeline

Study Start

February 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2012

Actual (reported)

Study Completion

November 2012

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 25 participants
Study completion date: November 2012
Actual (reported)
Listed locations: 2 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
July 8, 2009
Actual (reported)
First Posted
July 28, 2009
Actual (reported)
Study Start
February 2010
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
November 2012
Actual (reported)
Study Completion
November 2012
Actual (reported)

Last Updated: October 24, 2018
Status Verified: October 2018
Last Update Submitted: October 22, 2018

Conditions

Chemotherapy Induced Mucositis Mouth Pain

Keywords

Buprenorphine transdermal patch (BTDS)Moderate to severe mouth painChemotherapy induced mucositisPharmacokinetic

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

BuprenorphineDrug

Transdermal patch

Patch

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age2 Years - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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.

Sponsors & Collaborators

Mundipharma Research Limited
Industrylead

Study Sites (2)

Skejby, Denmark

Dr Howell

Liverpool, United Kingdom

MeSH Terms

Interventions

Buprenorphine

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
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 2010

Date type not reported

This date has not been verified as actual or estimated.

NCT02268422

Bioequivalence and Adhesion Comparison of Buprenorphine Patches

Phase 1Completed

NCT01276431

Norspan Efficacy and Safety Among Elderly Subjects

Phase 4Completed

NCT00949299

Effects of Buprenorphine on Ulnar Nerve Motor Block

Phase 4Terminated

NCT01071538

Buprenorphine for Late-Life Treatment Resistant Depression

Phase 2Completed

NCT00612287

Sublingual Buprenorphine for Chronic Pain

Phase 2Unknown

NCT00347815

Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

Phase 1Unknown

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.

Contact the study team to confirm eligibility.

Primary Completion

November 2012

Actual (reported)

Study Completion

November 2012

Actual (reported)

Last Updated

October 24, 2018

Record last verified: 2018-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00947466
Data provider: ClinicalTrials.gov
Source updated: 2018-10-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:52 UTC

Locations

DK(1)GB(1)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Patch

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Patch

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations