Healthy VolunteersPhase 1NCT01148537

The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers

A Phase 1 study testing Buprenorphine transdermal patch and Avelox (moxifloxacin hydrochloride) tablet in people with Healthy Volunteers, run by Purdue Pharma LP at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Buprenorphine transdermal patch and Avelox (moxifloxacin hydrochloride) tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 132 participants
Where: 1 siteUnited States
Study dates: Jul 2004to Dec 2004
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Males and females 18 to 55 years of age, inclusive.
Body weight ranging from 50 to 100 kilograms (kg) and a body mass index (BMI) ≤ 30 kg/m2.
Healthy as determined by unremarkable medical history, physical examination, vital signs, laboratory evaluations, electrocardiogram (ECG), and a 24-hour screening ECG telemetry.
Willing to refrain from strenuous exercise or contact sports during the study.
Female subjects must be surgically sterile or at least 2 years postmenopausal, or using an effective contraceptive method (intrauterine device, hormonal contraceptive, or double-barrier method).

Who cannot join

Any clinically significant illness during the 30 days prior to randomization.
Any history of allergy to buprenorphine, any excipient of BTDS, opioids, psychotropic or hypnotic drugs, and/or moxifloxacin or any member of the quinolone class of drugs.
A clinically significant history of allergic reaction to wound dressings or bandages.
Any medical or surgical conditions which might interfere with drug absorption (transdermal or gastrointestinal), distribution, metabolism, or excretion.
Abnormalities on physical examination, vital signs, ECG, or clinical laboratory values, unless those abnormalities are judged to be clinically insignificant by the Investigator.
Any cardiovascular disorders, including hypertension.

Show all 16Show fewer

Oxygen saturation (SpO2) ≤ 94% as measured by pulse oximetry.
Any personal or family history of prolonged QT interval or disorders of cardiac rhythm.
Abnormal cardiac condition denoted by any of the following:
QT interval ≥ 450 milliseconds (msec).
PR interval > 240 msec or ≤ 110 msec.
Evidence of second- or third-degree atrioventricular (AV) block.
Pathological Q-waves (defined as Q-wave > 40 msec or depth > 0.5 mV).
Evidence of ventricular preexcitation, complete left bundle branch block, right bundle branch block (RBBB), or incomplete RBBB.
A resting heart rate outside the range of 50 to 85 beats per minute (bpm).
Other protocol-specific exclusion/inclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

PPD Development, LP, Clinics
Austin, Texas, 78704

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo- & Positive-Controlled, Parallel Group, Dose Escalating Study to Evaluate the Effect of Buprenorphine Delivered by Buprenorphine Transdermal System at 10- and 40-mg Dose Levels on QT Intervals in Healthy Adult Volunteers

The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.

Read the detailed description

Drugs in this opioid class have been associated with prolonging QT interval/QT interval corrected for heart rate (QTc).

Conditions: Healthy Volunteers
Being tested: Buprenorphine transdermal patch, Matching placebo transdermal patch, Avelox (moxifloxacin hydrochloride) tablet
Keywords: Healthy subjects, Opioid, Transdermal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Buprenorphine transdermal patchDrug
Also called Butrans™
Buprenorphine transdermal patch 5, 10, 20, and 2 * 20 mcg/h.
Matching placebo transdermal patchDrug
Placebo transdermal patch to match BTDS 5, 10, 20, and 2 * 20.
Avelox (moxifloxacin hydrochloride) tabletDrug
Also called Avelox
Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13

Study groups in NCT01148537
Study group	Role	What they receive
BTDS	Experimental	Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h. Receives: Drug: Buprenorphine transdermal patch
Placebo TDS	Placebo comparator	Matching placebo transdermal patches 5, 10, 20 and 2 * 20. Receives: Drug: Matching placebo transdermal patch
Moxifloxacin	Active comparator	Moxifloxacin hydrochloride 400 mg tablets Receives: Drug: Avelox (moxifloxacin hydrochloride) tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13
Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.
Measured: Baseline to Day 13
The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13
Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.
Measured: Baseline to Day 13

Secondary outcomes (6)

The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.
Measured: Baseline to Day 6
The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.
Measured: Baseline to Day 6
The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (QT interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec.
Measured: Baseline to Day 6 and Day 13
The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec.
Measured: Baseline to Day 6 and Day 13
The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec.
Measured: Baseline to Day 6 and Day 13
The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec.
Measured: Baseline to Day 6 and Day 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2004Dec 2004

First posted22 Jun 2010 (estimated)
Study startJul 2004
Primary completionDec 2004
Study completionDec 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01148537
Sponsor's protocol ID: BUP1011
Status last verified: Aug 2012
First submitted: 21 Jun 2010
Last updated: 3 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo- & Positive-Controlled, Parallel Group, Dose Escalating Study to Evaluate the Effect of Buprenorphine Delivered by Buprenorphine Transdermal System at 10- and 40-mg Dose Levels on QT Intervals in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT01148537
Acronym / sponsor ID: BUP1011
Conditions: Healthy Volunteers
Keywords: Healthy subjects, Opioid, Transdermal
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Jul 2004
Primary completion: Dec 2004 (actual)
Study completion: Dec 2004 (actual)
First posted: 22 Jun 2010 (estimated)
Results: Posted 28 Sep 2010

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 examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.

Detailed description

Drugs in this opioid class have been associated with prolonging QT interval/QT interval corrected for heart rate (QTc).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
BTDS	Experimental	Drug: Buprenorphine transdermal patchBuprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
Placebo TDS	Placebo comparator	Drug: Matching placebo transdermal patchMatching placebo transdermal patches 5, 10, 20 and 2 * 20.
Moxifloxacin	Active comparator	Drug: Avelox (moxifloxacin hydrochloride) tabletMoxifloxacin hydrochloride 400 mg tablets

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Males and females 18 to 55 years of age, inclusive.
Body weight ranging from 50 to 100 kilograms (kg) and a body mass index (BMI) ≤ 30 kg/m2.
Healthy as determined by unremarkable medical history, physical examination, vital signs, laboratory evaluations, electrocardiogram (ECG), and a 24-hour screening ECG telemetry.
Willing to refrain from strenuous exercise or contact sports during the study.
Female subjects must be surgically sterile or at least 2 years postmenopausal, or using an effective contraceptive method (intrauterine device, hormonal contraceptive, or double-barrier method).

Key exclusion criteria (16 listed)

Any clinically significant illness during the 30 days prior to randomization.
Any history of allergy to buprenorphine, any excipient of BTDS, opioids, psychotropic or hypnotic drugs, and/or moxifloxacin or any member of the quinolone class of drugs.
A clinically significant history of allergic reaction to wound dressings or bandages.
Any medical or surgical conditions which might interfere with drug absorption (transdermal or gastrointestinal), distribution, metabolism, or excretion.
Abnormalities on physical examination, vital signs, ECG, or clinical laboratory values, unless those abnormalities are judged to be clinically insignificant by the Investigator.

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
Buprenorphine transdermal patchAlso: Butrans™Buprenorphine transdermal patch 5, 10, 20, and 2 * 20 mcg/h.	Drug	BTDS
Matching placebo transdermal patchPlacebo transdermal patch to match BTDS 5, 10, 20, and 2 * 20.	Drug	Placebo TDS
Avelox (moxifloxacin hydrochloride) tabletAlso: AveloxMoxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13	Drug	Moxifloxacin

Primary outcome

The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13
Time frame: Baseline to Day 13
Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.
The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13
Time frame: Baseline to Day 13
Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.

6 secondary outcomes

The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6
Time frame: Baseline to Day 6
The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6
Time frame: Baseline to Day 6
The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
Time frame: Baseline to Day 6 and Day 13
The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
Time frame: Baseline to Day 6 and Day 13
The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
Time frame: Baseline to Day 6 and Day 13
The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
Time frame: Baseline to Day 6 and Day 13

Results and safety

Results posted to the registry on 28 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BTDS	44	41
Placebo	44	44
Moxifloxacin	44	41

Primary outcome: The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13

Time frame: Baseline to Day 13. Least squares mean (Standard Deviation). Unit: QTci (msec)

Measure	BTDS n = 44	Placebo n = 44
Value	4.20 (7.44)	-1.71 (6.92)

BTDS vs Placebo: Mean Difference (Final Values): 5.91 (90% CI 3.4 to 8.4), p < .001, ANCOVA

Population analysed: The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded.

Primary outcome: The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13

Time frame: Baseline to Day 13. Least squares mean (Standard Deviation). Unit: QTci (msec)

Measure	Moxifloxacin n = 44	Placebo n = 44
Value	4.17 (7.22)	-1.69 (6.92)

Moxifloxacin vs Placebo: Mean Difference (Final Values): 5.86 (90% CI 3.3 to 8.4), p < .001, ANCOVA

Population analysed: The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.. Other adverse events reported at 4.50% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BTDS	0 of 44 (0%)	43 of 44 (97.7%)	Not reported
Placebo	0 of 44 (0%)	31 of 44 (70.5%)	Not reported
Moxifloxacin	1 of 44 (2.3%)	12 of 44 (27.3%)	Not reported

Limitations and caveats (from the sponsor): BUP1011 is a safety study. The comparison of buprenorphine vs placebo on QTc (interval corrected for heart rate) values is the primary outcome.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Buprenorphine transdermal patch and Avelox (moxifloxacin hydrochloride) tablet in people with Healthy Volunteers, run by Purdue Pharma LP at 1 site in United States.

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 5 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: finished, as of the sponsor's last update on 3 Sep 2012. 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 States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 28 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13 (time frame: Baseline to Day 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01148537.

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 3 Sep 2012.