PainPhase 1NCT02431624
An Assessment of Buprenorphine Transdermal Delivery System (BTDS) Patch Adhesion
A Phase 1 study testing BTDS in people with Pain, run by Mundipharma Research Limited at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the adhesion of BTDS patch 40 µg/h. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- BTDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Nov 2015
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Subjects to be excluded from the study are those who meet any of the following criteria:
- Female subjects who are pregnant or lactating.
- Any history of drug or alcohol abuse.
- Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of opioid or opioid antagonist-containing medication in the past 30 days.
- Any history of frequent nausea or vomiting regardless of aetiology.
Show all 24Show fewer
- Any history of seizures or symptomatic head trauma.
- Participation in a clinical drug study during the 90 days preceding the initial dose in this study, or participation in any other clinical drug study during this study.
- Any significant illness during the 4 weeks preceding entry into this study.
- A history of additional risk factors for Torsades de Pointes (e.g. heart failure, hypokalaemia, personal or family history of long QT syndrome, syncope, or family history of sudden death).
- Abnormal cardiac conditions including any of the following:
- QTcF interval greater than 450 msec at screening or at check-in before first dosing.
- Increase in QTcF of more than 60 msec above pre-dose values of each study period or QTcF > 500 msec at any time during the study.
- Use of medication within 5 times the half-life or minimum 14 days for prescription medication or 7 days for over-the-counter preparations (including vitamins, herbal and/or mineral supplements), whichever is longer, before the first dose of study treatment and during the study (with the exception of the continued use of Hormone Replacement Therapy (HRT) and contraceptives).
- Refusal to abstain from caffeine or xanthine containing beverages and grapefruit juice within 48 hours before IMP administration until after the last study measure has been performed in each study period.
- Weekly alcohol intake exceeding the equivalent of 14 units/week for females and 21 units/week for males.
- Consumption of alcoholic beverages within 48 hours before IMP administration, and refusal to abstain from alcohol for the duration of the study confinement and for at least 48 hours after the last naltrexone dose in each study period.
- History of smoking within 45 days of IMP administration and refusal to abstain from smoking during the study.
- Positive results of urine drug screen, alcohol test and pregnancy test.
- Known sensitivity to buprenorphine, naltrexone, related compounds or any of the excipients or any contraindications as detailed in the Butrans Summary of Product Characteristics or Nemexin Summary of Product Characteristics.
- Clinically significant history of allergic reaction to wound dressings or elastoplast.
- Subjects with any dermatological disorder or tattoos at the proposed sites of patch application, or with a history of eczema/cutaneous atrophy.
- Subjects who will not allow hair to be removed at the proposed patch application sites which may prevent proper placement of the patch.
- Refusal to allow their primary care physician to be informed of participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two Period, Randomised, Open-label, Crossover Study to Assess the Adhesion of Buprenorphine Transdermal Delivery System 40 µg/h Patch and 20 µg/h Patch, in Healthy Volunteers
The purpose of this study is to assess the adhesion of BTDS patch 40 µg/h.
Read the detailed description
The objective is to show non-inferiority in adhesion of BTDS patch 40 µg/h compared to BTDS patch 20 µg/h. Safety and tolerability of both patches will also be assessed.
- Conditions
- Pain
- Being tested
- BTDS
- Keywords
- Healthy Volunteer
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTDSDrug
| Study group | Role | What they receive |
|---|---|---|
| Test treatment | Experimental | BTDS 40 milligram Receives: Drug: BTDS |
| Reference treatment | Active comparator | BTDS 20 milligram Receives: Drug: BTDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patch Adhesion score
Measured: 7 days
Secondary outcomes (6)
Observer Rating Scale of Patch prior to Removal questionnaire
does the patch shift, buckle, curl, fall off, change colour or smell
Measured: 7 days
Skin reaction assessment score
Measured: day 8
Adverse Events
Measured: Up to 7-10 days post patch removal
Changes in haematology and biochemistry values
Measured: Up to 7-10 days after last patch removal
Vital signs
Measured: Up to 7-10 days after last patch removal
ECG
Measured: Up to 7-10 days after last patch removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT02431624
- Sponsor's protocol ID
- BUP1508
- Other IDs
- 2014-003421-18, 2014
- Status last verified
- Feb 2016
- First submitted
- 25 Feb 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Period, Randomised, Open-label, Crossover Study to Assess the Adhesion of Buprenorphine Transdermal Delivery System 40 µg/h Patch and 20 µg/h Patch, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02431624
- Acronym / sponsor ID
- BUP1508
- Conditions
- Pain
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 May 2015 (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 assess the adhesion of BTDS patch 40 µg/h.
Detailed description
The objective is to show non-inferiority in adhesion of BTDS patch 40 µg/h compared to BTDS patch 20 µg/h. Safety and tolerability of both patches will also be assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test treatment | Experimental | Drug: BTDSBTDS 40 milligram |
| Reference treatment | Active comparator | Drug: BTDSBTDS 20 milligram |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- Female subjects who are pregnant or lactating.
- Any history of drug or alcohol abuse.
- Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of opioid or opioid antagonist-containing medication in the past 30 days.
- Any history of frequent nausea or vomiting regardless of aetiology.
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 |
|---|---|---|
| BTDS | Drug | Reference treatment, Test treatment |
Primary outcome
Patch Adhesion score
Time frame: 7 days
6 secondary outcomes
Observer Rating Scale of Patch prior to Removal questionnaire
Time frame: 7 days
Skin reaction assessment score
Time frame: day 8
Adverse Events
Time frame: Up to 7-10 days post patch removal
Changes in haematology and biochemistry values
Time frame: Up to 7-10 days after last patch removal
Vital signs
Time frame: Up to 7-10 days after last patch removal
ECG
Time frame: Up to 7-10 days after last patch removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BTDS in people with Pain, run by Mundipharma Research Limited at 1 site in United Kingdom.
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 0 inclusion and 24 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: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patch Adhesion score (time frame: 7 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 9 Feb 2016.