Chemotherapy Induced MucositisPhase 1/2BUP1501NCT00947466
A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain
A Phase 1/2 study testing Buprenorphine in people with Chemotherapy Induced Mucositis and Mouth Pain, run by Mundipharma Research Limited at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Chemotherapy Induced Mucositis, Mouth Pain
- What is being tested?
- Buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2010to Nov 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 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.
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
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.
Read the 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
- Being tested
- Buprenorphine
- Keywords
- Buprenorphine transdermal patch (BTDS), Moderate to severe mouth pain, Chemotherapy induced mucositis, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| Patch | Experimental | Not described Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterise the pharmacokinetics of BTDS 5-20 ug/h in children weighing >15kg
Measured: PK's taken daily for 12 days
Secondary outcomes (1)
safety & tolerability of BTDS 5-20ug/h in children
Measured: every 4 hours to day 5, day 12 and day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startFeb 2010
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: 25 patients have been recruited and it was considered that further recruitment would add no extra PK information
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947466
- Sponsor's protocol ID
- BUP1501
- Other IDs
- 2008-002428-27, 2008
- Acronym
- BUP1501
- Status last verified
- Oct 2018
- First submitted
- 8 Jul 2009
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00947466
- Acronym / sponsor ID
- BUP1501 / BUP1501
- Conditions
- Chemotherapy Induced Mucositis, Mouth Pain
- Keywords
- Buprenorphine transdermal patch (BTDS), Moderate to severe mouth pain, Chemotherapy induced mucositis, Pharmacokinetic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 25 patients have been recruited and it was considered that further recruitment would add no extra PK information
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patch | Experimental | Drug: Buprenorphine |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuprenorphineTransdermal patch | Drug | Patch |
Primary outcome
To characterise the pharmacokinetics of BTDS 5-20 ug/h in children weighing >15kg
Time frame: PK's taken daily for 12 days
1 secondary outcome
safety & tolerability of BTDS 5-20ug/h in children
Time frame: every 4 hours to day 5, day 12 and day 21
Results and safety
The study was stopped early (reason given: 25 patients have been recruited and it was considered that further recruitment would add no extra PK information). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Results available onw ebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Buprenorphine in people with Chemotherapy Induced Mucositis and Mouth Pain, run by Mundipharma Research Limited at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 25 patients have been recruited and it was considered that further recruitment would add no extra PK information). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterise the pharmacokinetics of BTDS 5-20 ug/h in children weighing >15kg (time frame: PK's taken daily for 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.