Nicotine DependenceNCT03700112
Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.
A study testing JUUL Virginia Tobacco flavored 5.0% ENDS, PMI iQOS Heat sticks and Reynolds VUSE Solo ENDS - Original in people with Nicotine Dependence and Nicotine Dependence, Cigarettes, run by Juul Labs, Inc. at 1 site in New Zealand.
Trial summary
A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use
- What is being tested?
- JUUL Virginia Tobacco flavored 5.0% ENDS, PMI iQOS Heat sticks and Reynolds VUSE Solo ENDS - Original
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNew Zealand
- Study dates
- 4 Dec 2018to 9 Apr 2019
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 to 60 years of age inclusive.
- BMI between 18 to 35 kg / m2 inclusive.
- Healthy based on medical history and screening assessments, in the opinion of the Investigator.
- Current smoker of at least 8 cigarettes per day on average.
- Has been smoking for at least 12 months prior to screening. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) are permitted at the discretion of the Investigator.
- Able to participate, and willing to give written informed consent and comply with study restrictions.
Who cannot join
- Clinically relevant medical or psychiatric disorder, in the opinion of the Investigator.
- Clinically significant abnormality on screening ECG.
- Sustained blood pressure recordings at screening of < 90 mmHg or > 150 mmHg for systolic blood pressure, or < 50 mmHg or > 90 mmHg for diastolic blood pressure.
- Sustained resting heart rate of > 100 or < 40 beats per minute at screening.
- Positive result for urine drugs of abuse test or alcohol breath test at screening. If a positive urine drug test is observed, and it is believed the positive urine test is due to prescription drugs, the PI should obtain documentation that a) confirms the subject's use of the prescribed medication, and b) the prescribed medication will cause a false positive drug test.
- Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
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- Exposure to an investigational drug in a clinical trial within 1 month prior toAssessment Day 1.
- Blood or plasma donation of > 500 mL within 1 month prior to Assessment Day 1.
- Positive urine pregnancy test at screening or Assessment Day 1 in female subject.
- Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Christchurch Clinical Studies Trust Ltd
Christchurch, 8011
About this study
Official title: An Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 Puff and Ad-libitum) Conditions, in Healthy Adult Smokers.
A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers
Read the detailed description
E- cigarettes may be an acceptable alternative to traditional cigarette smoking. By utilizing vaporization rather than combustion, the generation and inhalation of HPHCs, smoke, and carbon monoxide (CO) may be reduced or avoided. This study will provide an understanding of the in vitro levels of nicotine obtained with use of the company's ENDS products compared to competitor products marketed in the United States of America (USA), and to a popular brand of combustible cigarette smoked in the USA.
- Being tested
- JUUL Virginia Tobacco flavored 5.0% ENDS, PMI iQOS Heat sticks, Reynolds VUSE Solo ENDS - Original, Imperial MyBlu ENDS - Original, Altria MarkTen ENDS - Bold Classic
- Keywords
- Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use, Tobacco Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUUL Virginia Tobacco flavored 5.0% ENDSOther
Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum
PMI iQOS Heat sticksOther
PMI IQOS Heat sticks is administered using a controlled method and ad-libitum
Reynolds VUSE Solo ENDS - OriginalOther
Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum
Imperial MyBlu ENDS - OriginalOther
Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum
Altria MarkTen ENDS - Bold ClassicOther
Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum
MLV PHIX ENDS - Original TobaccoOther
MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum
NJOY Daily EXTRA ENDS - Rich TobaccoOther
NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum
Altria Marlboro combustible cigarette - RedOther
Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum
| Study group | Role | What they receive |
|---|---|---|
| JUUL Virginia Tobacco flavored 5.0% ENDS | Experimental | Administration of JUUL Virginia Tobacco flavored 5.0% ENDS product consumed using 10 puffs delivery method
Administration of JUUL Virginia Tobacco flavored 5.0% ENDS product consumed Ad-libitum delivery method Receives: Other: JUUL Virginia Tobacco flavored 5.0% ENDS |
| PMI iQOS Heat sticks | Experimental | Administration of PMI iQOS Heat sticks - Regular consumed using 10 puffs delivery method
Administration of PMI iQOS Heat sticks - Regular consumed ad-libitum delivery method Receives: Other: PMI iQOS Heat sticks |
| Reynolds VUSE Solo ENDS - Original | Experimental | Administration of Reynolds VUSE Solo ENDS - Original consumed using 10 puffs delivery method
Administration of Reynolds VUSE Solo ENDS - Original consumed using ad-libitum delivery method Receives: Other: Reynolds VUSE Solo ENDS - Original |
| Imperial MyBlu ENDS - Original | Experimental | Administration of Imperial MyBlu ENDS - Original consumed using 10 puffs delivery method
Administration of Imperial MyBlu ENDS - Original consumed using ad-libitum delivery method Receives: Other: Imperial MyBlu ENDS - Original |
| Altria MarkTen ENDS - Bold Classic | Experimental | Administration of Altria MarkTen ENDS - Bold Classic consuming using 10 puffs delivery method
Administration of Altria MarkTen ENDS - Bold Classic consuming using ad-libitum delivery method Receives: Other: Altria MarkTen ENDS - Bold Classic |
| MLV PHIX ENDS - Original Tobacco | Experimental | Administration of MLV PHIX ENDS - Original Tobacco consumed using 10 puffs delivery method
Administration of with MLV PHIX ENDS - Original Tobacco consumed using ad-libitum delivery method Receives: Other: MLV PHIX ENDS - Original Tobacco |
| NJOY Daily EXTRA ENDS - Rich Tobacco | Experimental | Administration of NJOY Daily EXTRA ENDS - Rich Tobacco consumed using 10 puffs delivery method
Administration of NJOY Daily EXTRA ENDS - Rich Tobacco consumed using delivery method and ad-libitum Receives: Other: NJOY Daily EXTRA ENDS - Rich Tobacco |
| Altria Marlboro combustible cigarette - Red | Experimental | Administration of Altria Marlboro combustible cigarette - Red consumed using 10 puffs delivery method Administration of Altria Marlboro combustible cigarette - Red consumed using ad-libitum delivery method Receives: Other: Altria Marlboro combustible cigarette - Red |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
To estimate nicotine pharmacokinetics (PK) profiles across 8 E-Cigarette/cigarette products within-each and between-all delivery conditions (10 puffs versus ad libitum puffs) using Area Under the nicotine concentration-time curve (AUC1hour) calculated using linear trapezoidal summation from time zero (defined as the start of product use) to 60 minutes.
Measured: 48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using AUC1hour-baseline (baseline adjusted AUC1hour)
Measured: 48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax (Maximum measured plasma concentration over the duration of the measurement interval.
Measured: 48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax-baseline(Baseline adjusted Cmax)
Measured: 48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Tmax(Time of the maximum measured plasma concentration over the duration of the measurement interval. If the maximum value occurs at more than one time point within the time span specified, Tmax is defined as the first time point with this value
Measured: 48 days
Secondary outcomes (3)
Measure exhaled Carbon Monoxide change in all product administration periods
To estimate change in exhaled carbon monoxide (CO) for 8 E-cigarettes/cigarettes Products, in all product administration periods under 2 different delivery (10 puff and ad-libitum) conditions. Exhaled CO will be measured 5-15 minutes prior to initiation of the first inhalation, and up to 15 minutes after the collection of the 30 minute PK sample
Measured: 48 days
Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale
To characterize measures of subjective effects with use of 8 E-cigarettes/cigarettes Products under 2 different delivery (10 puff and ad-libitum) conditions using a modified Product Evaluations Scale questionnaire using scale below after collection of the 30-minute PK sample and exhaled CO measurement.
Change in Evaluation: 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, 7= extremely
Four multi- item subscales will be derived from "Satisfaction" (questions 1, 2, 3, and 12); "Psychological Reward" (questions 4 through 8); "Aversion" (questions 9, 10, 16, and 18) and "Relief" (questions 11, 13, 14, 15, and reversed for question 19) and single questions 17 and 20 will be summarized.
Measured: 48 days
Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette
To characterize consumptions of 8 E-cigarettes/cigarettes products within-each and between-all delivery conditions (10 puffs versus ad-libitum puffs), by collecting total number of puffs.
Measured: 48 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start4 Dec 2018
- Primary completion24 Feb 2019
- Study completion9 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juul Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Concetta Carbonaro, Study director, JUUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700112
- Sponsor's protocol ID
- PROT-00013
- Status last verified
- Jan 2019
- First submitted
- 18 Sep 2018
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 Puff and Ad-libitum) Conditions, in Healthy Adult Smokers.
- ClinicalTrials.gov ID
- NCT03700112
- Acronym / sponsor ID
- PROT-00013
- Keywords
- Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Juul Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 24 Feb 2019 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 9 Oct 2018 (actual)
- 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.
A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers
Detailed description
E- cigarettes may be an acceptable alternative to traditional cigarette smoking. By utilizing vaporization rather than combustion, the generation and inhalation of HPHCs, smoke, and carbon monoxide (CO) may be reduced or avoided. This study will provide an understanding of the in vitro levels of nicotine obtained with use of the company's ENDS products compared to competitor products marketed in the United States of America (USA), and to a popular brand of combustible cigarette smoked in the USA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| JUUL Virginia Tobacco flavored 5.0% ENDS | Experimental | Other: JUUL Virginia Tobacco flavored 5.0% ENDSAdministration of JUUL Virginia Tobacco flavored 5.0% ENDS product consumed using 10 puffs delivery method Administration of JUUL Virginia Tobacco flavored 5.0% ENDS product consumed Ad-libitum delivery method |
| PMI iQOS Heat sticks | Experimental | Other: PMI iQOS Heat sticksAdministration of PMI iQOS Heat sticks - Regular consumed using 10 puffs delivery method Administration of PMI iQOS Heat sticks - Regular consumed ad-libitum delivery method |
| Reynolds VUSE Solo ENDS - Original | Experimental | Other: Reynolds VUSE Solo ENDS - OriginalAdministration of Reynolds VUSE Solo ENDS - Original consumed using 10 puffs delivery method Administration of Reynolds VUSE Solo ENDS - Original consumed using ad-libitum delivery method |
| Imperial MyBlu ENDS - Original | Experimental | Other: Imperial MyBlu ENDS - OriginalAdministration of Imperial MyBlu ENDS - Original consumed using 10 puffs delivery method Administration of Imperial MyBlu ENDS - Original consumed using ad-libitum delivery method |
| Altria MarkTen ENDS - Bold Classic | Experimental | Other: Altria MarkTen ENDS - Bold ClassicAdministration of Altria MarkTen ENDS - Bold Classic consuming using 10 puffs delivery method Administration of Altria MarkTen ENDS - Bold Classic consuming using ad-libitum delivery method |
| MLV PHIX ENDS - Original Tobacco | Experimental | Other: MLV PHIX ENDS - Original TobaccoAdministration of MLV PHIX ENDS - Original Tobacco consumed using 10 puffs delivery method Administration of with MLV PHIX ENDS - Original Tobacco consumed using ad-libitum delivery method |
| NJOY Daily EXTRA ENDS - Rich Tobacco | Experimental | Other: NJOY Daily EXTRA ENDS - Rich TobaccoAdministration of NJOY Daily EXTRA ENDS - Rich Tobacco consumed using 10 puffs delivery method Administration of NJOY Daily EXTRA ENDS - Rich Tobacco consumed using delivery method and ad-libitum |
| Altria Marlboro combustible cigarette - Red | Experimental | Other: Altria Marlboro combustible cigarette - RedAdministration of Altria Marlboro combustible cigarette - Red consumed using 10 puffs delivery method Administration of Altria Marlboro combustible cigarette - Red consumed using ad-libitum delivery method |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female aged 18 to 60 years of age inclusive.
- BMI between 18 to 35 kg / m2 inclusive.
- Healthy based on medical history and screening assessments, in the opinion of the Investigator.
- Current smoker of at least 8 cigarettes per day on average.
- Has been smoking for at least 12 months prior to screening. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) are permitted at the discretion of the Investigator.
Key exclusion criteria (10 listed)
- Clinically relevant medical or psychiatric disorder, in the opinion of the Investigator.
- Clinically significant abnormality on screening ECG.
- Sustained blood pressure recordings at screening of < 90 mmHg or > 150 mmHg for systolic blood pressure, or < 50 mmHg or > 90 mmHg for diastolic blood pressure.
- Sustained resting heart rate of > 100 or < 40 beats per minute at screening.
- Positive result for urine drugs of abuse test or alcohol breath test at screening. If a positive urine drug test is observed, and it is believed the positive urine test is due to prescription drugs, the PI should obtain documentation that a) confirms the subject's use of the prescribed medication, and b) the prescribed medication will cause a false positive drug test.
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 |
|---|---|---|
| JUUL Virginia Tobacco flavored 5.0% ENDSVirginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum | Other | JUUL Virginia Tobacco flavored 5.0% ENDS |
| PMI iQOS Heat sticksPMI IQOS Heat sticks is administered using a controlled method and ad-libitum | Other | PMI iQOS Heat sticks |
| Reynolds VUSE Solo ENDS - OriginalReynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum | Other | Reynolds VUSE Solo ENDS - Original |
| Imperial MyBlu ENDS - OriginalImperial MyBlu ENDS- original is administered using a controlled method and ad-libitum | Other | Imperial MyBlu ENDS - Original |
| Altria MarkTen ENDS - Bold ClassicAltria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum | Other | Altria MarkTen ENDS - Bold Classic |
| MLV PHIX ENDS - Original TobaccoMLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum | Other | MLV PHIX ENDS - Original Tobacco |
| NJOY Daily EXTRA ENDS - Rich TobaccoNJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum | Other | NJOY Daily EXTRA ENDS - Rich Tobacco |
| Altria Marlboro combustible cigarette - RedAltria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum | Other | Altria Marlboro combustible cigarette - Red |
Primary outcome
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Time frame: 48 days
To estimate nicotine pharmacokinetics (PK) profiles across 8 E-Cigarette/cigarette products within-each and between-all delivery conditions (10 puffs versus ad libitum puffs) using Area Under the nicotine concentration-time curve (AUC1hour) calculated using linear trapezoidal summation from time zero (defined as the start of product use) to 60 minutes.
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Time frame: 48 days
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using AUC1hour-baseline (baseline adjusted AUC1hour)
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Time frame: 48 days
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax (Maximum measured plasma concentration over the duration of the measurement interval.
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Time frame: 48 days
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax-baseline(Baseline adjusted Cmax)
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Time frame: 48 days
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Tmax(Time of the maximum measured plasma concentration over the duration of the measurement interval. If the maximum value occurs at more than one time point within the time span specified, Tmax is defined as the first time point with this value
3 secondary outcomes
Measure exhaled Carbon Monoxide change in all product administration periods
Time frame: 48 days
Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale
Time frame: 48 days
Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette
Time frame: 48 days
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 14 Jun 2021.
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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.
Concetta Carbonaro study director
JUUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUUL Virginia Tobacco flavored 5.0% ENDS, PMI iQOS Heat sticks and Reynolds VUSE Solo ENDS - Original in people with Nicotine Dependence and Nicotine Dependence, Cigarettes, run by Juul Labs, Inc. at 1 site in New Zealand.
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 10 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 14 Jun 2021. 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 New Zealand. 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.
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?
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP. (time frame: 48 days). The study lists 5 primary outcomes in all. 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 14 Jun 2021.