ECG EffectsPhase 1NCT01999114
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers
A Phase 1 study testing Buprenorphine transdermal patch, Naltrexone tablet and Moxifloxacin tablet in people with ECG Effects, run by Purdue Pharma LP at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- ECG Effects
- What is being tested?
- Buprenorphine transdermal patch, Naltrexone tablet and Moxifloxacin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Oct 2012
- 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
- Provide written informed consent.
- Males and females aged 18 to 55, inclusive.
- Body weight ranging from 50 to 100 kilograms (kg) (110 to 220 lbs) and body mass index (BMI) ranging from 18 to 30 (kg/m2), inclusive.
- Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and resting 12-lead ECG.
- Females of child-bearing potential must be using an adequate and reliable method of contraception (ie, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception). Females who are postmenopausal must have been postmenopausal ≥ 1 year and have elevated serum follicle stimulating hormone (FSH).
- Willing to eat the food supplied during the study.
- Willing to refrain from strenuous exercise during the entire study. Subjects will not begin a new exercise program nor participate in any unusually strenuous physical exertion.
- All 8 anatomical transdermal system (TDS) application sites (upper back, upper chest, upper outer arm, or lateral thorax) must be acceptable for study use.
Who cannot join
- Females who are pregnant (positive beta human chorionic gonadotropin test) or lactating.
- Current or recent (within 5 years) history of drug or alcohol abuse.
- History or any current conditions that might interfere with drug absorption (transdermal or gastrointestinal), distribution, metabolism or excretion.
- Use of an opioid-containing medication in the past 30 days preceding the initial dose in this study.
- Known allergy to buprenorphine, any excipient of BTDS, opioids, psychotropic or hypnotic drugs, and/or moxifloxacin or any member of the quinolone class drugs.
- Any history of frequent nausea or emesis regardless of etiology.
Show all 36Show fewer
- Any history of seizures or head trauma with sequelae.
- Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
- Any significant illness during the 30 days preceding the initial dose in this study.
- Use of any medication including thyroid hormonal therapy (hormonal contraception and hormonal replacement therapy in the form of estrogen with or without progestin is allowed), vitamins, herbal and/or mineral supplements during the 7 days preceding the initial dose.
- Any personal or family history of prolonged QT interval or disorders of cardiac rhythm.
- Abnormal cardiac conditions including hypertension.
- Abnormal cardiac condition denoted by any of the following:
- QTcF interval > 450 milliseconds (msec)
- PR interval > 240 msec or QRS > 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 pre-excitation, complete left bundle branch block, right bundle branch block (RBBB), or incomplete RBBB
- With a resting heart rate outside the range of 45 to 85 beats per minute (bpm)
- Abnormalities on physical examination, vital signs, ECG, or clinical laboratory values, unless those abnormalities were judged clinically insignificant by the investigator.
- Oxygen saturation (SpO2) ≤ 94% as measured by pulse oximetry.
- Refusal to abstain from caffeine or xanthine containing beverages entirely during confinement.
- Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration and any time during study.
- History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test
- Blood or blood products donated within 30 days prior to study drug administration or anytime during the study.
- Positive results of urine drug screen or alcohol screen.
- Positive results of hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV).
- Positive naloxone challenge test.
- Presence of Gilbert's Syndrome, or any known hepatobiliary abnormalities.
- The investigator believes the subject to be unsuitable for reason(s) not specifically stated in the exclusion criteria.
- Subjects who have allergies or other contraindications to transdermal systems or patch adhesives.
- Clinically significant history of allergic reaction to wound dressings or elastoplast.
- Subjects with a dermatological disorder at any relevant patch application site that precludes proper placement and/or rotation of patch.
- Taking antihistamines within 72 hours prior to dosing or systemic or topical corticosteroids within 3 weeks prior to dosing.
- Subjects will not allow hair to be removed at the proposed patch application site which may prevent proper placement of the patch.
- Subjects for whom a proper assessment of possible application site reactions would be confounded by local skin conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Triple-blind, Placebo- and Positive-Controlled, Parallel Group Study of the Effect of Buprenorphine Delivered by the Buprenorphine Transdermal System (BTDS) at Doses up to 80 mcg/Hour and Naltrexone on ECG Intervals in Healthy Adult Subjects
The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.
- Conditions
- ECG Effects
- Being tested
- Buprenorphine transdermal patch, Naltrexone tablet, Placebos (for TDS and for naltrexone and for moxifloxacin), Moxifloxacin tablet
- Keywords
- Healthy subjects, Opioid, Transdermal, ECG
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 patch applied transdermally
Naltrexone tabletDrug
Also called ReVia
Naltrexone tablet; 1 tablet taken orally every 12 hours
Placebos (for TDS and for naltrexone and for moxifloxacin)Drug
Matching placebos
Moxifloxacin tabletDrug
Also called Avelox®
Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17
| Study group | Role | What they receive |
|---|---|---|
| BTDS | Experimental | Buprenorphine transdermal patches 10, 40 (2 x 20), and 80 (4 x 20) mcg/hr Receives: Drug: Buprenorphine transdermal patch |
| BTDS with naltrexone | Experimental | Buprenorphine transdermal patches 10, 40 (2 x 20), and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets Receives: Drug: Buprenorphine transdermal patch; Drug: Naltrexone tablet |
| Naltrexone | Active comparator | Naltrexone 50 mg tablets Receives: Drug: Naltrexone tablet |
| Placebo | Placebo comparator | Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets Receives: Drug: Placebos (for TDS and for naltrexone and for moxifloxacin) |
| Moxifloxacin | Active comparator | Moxifloxacin 400-mg tablets Receives: Drug: Moxifloxacin tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
The effects of 10 mcg/hr buprenorphine (Day 6) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 10 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.
Measured: Baseline to Day 6
The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
The effects of 40 mcg/hr buprenorphine (Day 13) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 40 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.
Measured: Baseline to Day 13
The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
The effects of 80 mcg/hr buprenorphine (Day 17) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 80 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.
Measured: Baseline to Day 17
Secondary outcomes (9)
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Measured: Baseline to Day 6
Heart Rate (HR)
Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Measured: Baseline to Day 6
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Measured: Baseline to Day 13
Heart Rate (HR)
Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Measured: Baseline to Day 13
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Measured: Baseline to Day 17
Heart Rate (HR)
Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Measured: Baseline to Day 17
ECG Morphology
Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:
- Second degree heart block
- Third degree heart block
- Complete right bundle branch block (RBBB)
- Complete left bundle branch block (LBBB)
- ST segment changes (elevation and depression separately)
- T-wave abnormalities (negative T waves only)
- Myocardial infarction (MI) pattern
- Any new abnormal U waves
Measured: Baseline to Day 6
ECG Morphology
Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:
- Second degree heart block
- Third degree heart block
- Complete right bundle branch block (RBBB)
- Complete left bundle branch block (LBBB)
- ST segment changes (elevation and depression separately)
- T-wave abnormalities (negative T waves only)
- Myocardial infarction (MI) pattern
- Any new abnormal U waves
Measured: Baseline to Day 13
ECG Morphology
Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:
- Second degree heart block
- Third degree heart block
- Complete right bundle branch block (RBBB)
- Complete left bundle branch block (LBBB)
- ST segment changes (elevation and depression separately)
- T-wave abnormalities (negative T waves only)
- Myocardial infarction (MI) pattern
- Any new abnormal U waves
Measured: Baseline to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ECG EffectsStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999114
- Sponsor's protocol ID
- BUP1025
- Status last verified
- Feb 2018
- First submitted
- 19 Nov 2013
- Last updated
- 5 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Harris SC, Morganroth J, Ripa SR, Thorn MD, Colucci S. Effects of buprenorphine on QT intervals in healthy subjects: results of 2 randomized positive- and placebo-controlled trials. Postgrad Med. 2017 Jan;129(1):69-80. doi: 10.1080/00325481.2017.1270156.
PubMed 27927048
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo- and Positive-Controlled, Parallel Group Study of the Effect of Buprenorphine Delivered by the Buprenorphine Transdermal System (BTDS) at Doses up to 80 mcg/Hour and Naltrexone on ECG Intervals in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01999114
- Acronym / sponsor ID
- BUP1025
- Conditions
- ECG Effects
- Keywords
- Healthy subjects, Opioid, Transdermal, ECG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Posted 5 Nov 2018
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 evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BTDS | Experimental | Drug: Buprenorphine transdermal patchBuprenorphine transdermal patches 10, 40 (2 x 20), and 80 (4 x 20) mcg/hr |
| BTDS with naltrexone | Experimental | Drug: Buprenorphine transdermal patch, Drug: Naltrexone tabletBuprenorphine transdermal patches 10, 40 (2 x 20), and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets |
| Naltrexone | Active comparator | Drug: Naltrexone tabletNaltrexone 50 mg tablets |
| Placebo | Placebo comparator | Drug: Placebos (for TDS and for naltrexone and for moxifloxacin)Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin tabletMoxifloxacin 400-mg tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Provide written informed consent.
- Males and females aged 18 to 55, inclusive.
- Body weight ranging from 50 to 100 kilograms (kg) (110 to 220 lbs) and body mass index (BMI) ranging from 18 to 30 (kg/m2), inclusive.
- Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and resting 12-lead ECG.
- Females of child-bearing potential must be using an adequate and reliable method of contraception (ie, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception). Females who are postmenopausal must have been postmenopausal ≥ 1 year and have elevated serum follicle stimulating hormone (FSH).
Key exclusion criteria (36 listed)
- Females who are pregnant (positive beta human chorionic gonadotropin test) or lactating.
- Current or recent (within 5 years) history of drug or alcohol abuse.
- History or any current conditions that might interfere with drug absorption (transdermal or gastrointestinal), distribution, metabolism or excretion.
- Use of an opioid-containing medication in the past 30 days preceding the initial dose in this study.
- Known allergy to buprenorphine, any excipient of BTDS, opioids, psychotropic or hypnotic drugs, and/or moxifloxacin or any member of the quinolone class drugs.
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: ButransBuprenorphine patch applied transdermally | Drug | BTDS, BTDS with naltrexone |
| Naltrexone tabletAlso: ReViaNaltrexone tablet; 1 tablet taken orally every 12 hours | Drug | BTDS with naltrexone, Naltrexone |
| Placebos (for TDS and for naltrexone and for moxifloxacin)Matching placebos | Drug | Placebo |
| Moxifloxacin tabletAlso: Avelox®Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17 | Drug | Moxifloxacin |
Primary outcome
The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
Time frame: Baseline to Day 6
The effects of 10 mcg/hr buprenorphine (Day 6) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 10 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.
The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
Time frame: Baseline to Day 13
The effects of 40 mcg/hr buprenorphine (Day 13) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 40 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.
The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
Time frame: Baseline to Day 17
The effects of 80 mcg/hr buprenorphine (Day 17) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 80 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.
9 secondary outcomes
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
Time frame: Baseline to Day 6
Heart Rate (HR)
Time frame: Baseline to Day 6
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
Time frame: Baseline to Day 13
Heart Rate (HR)
Time frame: Baseline to Day 13
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
Time frame: Baseline to Day 17
Heart Rate (HR)
Time frame: Baseline to Day 17
ECG Morphology
Time frame: Baseline to Day 6
ECG Morphology
Time frame: Baseline to Day 13
ECG Morphology
Time frame: Baseline to Day 17
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27927048Harris SC, Morganroth J, Ripa SR, Thorn MD, Colucci S. Effects of buprenorphine on QT intervals in healthy subjects: results of 2 randomized positive- and placebo-controlled trials. Postgrad Med. 2017 Jan;129(1):69-80. doi: 10.1080/00325481.2017.1270156.
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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, Naltrexone tablet and Moxifloxacin tablet in people with ECG Effects, 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 8 inclusion and 36 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 5 Nov 2018. 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 5 Nov 2018). 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 Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI) (time frame: Baseline to Day 6). The study lists 3 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 NCT01999114, which also lists 1 linked publication.
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 5 Nov 2018.