UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045304 |
|---|---|
| Receipt number | R000051745 |
| Scientific Title | A study to evaluate exposure to selected smoke constituents in healthy adult smokers using novel heated tobacco product DT3.0a for 5 days under clinical confinement |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2023/10/03 09:05:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to evaluate exposure to selected smoke constituents when using novel heated tobacco product DT3.0a
Acronym
A study to evaluate exposure to selected smoke constituents when using novel heated tobacco product DT3.0a
Scientific Title
A study to evaluate exposure to selected smoke constituents in healthy adult smokers using novel heated tobacco product DT3.0a for 5 days under clinical confinement
Scientific Title:Acronym
A study to evaluate exposure to selected smoke constituents in healthy adult smokers using novel heated tobacco product DT3.0a for 5 days under clinical confinement
Region
| Japan |
Condition
Condition
Smokers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate exposure to selected smoke constituents in healthy adult smokers using novel heated tobacco product DT3.0a for 5 days under clinical confinement.
Basic objectives2
Others
Basic objectives -Others
To investigate the levels of biomarkers of exposure to selected smoke constituents when using heated tobacco products (DT3.0a, mDT3.0a, THS) and abstaining from smoking for 5 days relative to smoking cigarettes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of biomarkers of exposure to selected smoke constituents between the investigational groups
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
<Non-menthol Smokers> Use of subject's own brand cigarette for 2 days (clinical confinement)- Use of heated tobacco product DT3.0a for 5 days (clinical confinement)
Interventions/Control_2
<Non-menthol Smokers> Use of subject's own brand cigarette for 2 days (clinical confinement) - Use of heated tobacco product THS for 5 days (clinical confinement)
Interventions/Control_3
<Non-menthol Smokers> Use of subject's own brand cigarette for 2 days (clinical confinement) - Continued use of subject's own brand cigarette for 5 days (clinical confinement)
Interventions/Control_4
<Non-menthol Smokers> Use of subject's own brand cigarette for 2 days (clinical confinement) - Abstinence from smoking for 5 days (clinical confinement)
Interventions/Control_5
<Menthol Smokers> Use of subject's own brand cigarette for 2 days (clinical confinement) - Use of heated tobacco product mDT3.0a for 5 days (clinical confinement)
Interventions/Control_6
<Menthol Smokers> Use of subject's own brand cigarette for 2 days (clinical confinement) - Continued use of subject's own brand cigarette for 5 days (clinical confinement)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 21 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Subjects who sign the study-specific consent form
- Subjects who are confirmed to be in good health from all of the inspection results
- Subjects who smoke commercial cigarettes more than one year
etc.
Key exclusion criteria
- Subjects who have used tobacco products other than commercial cigarettes (i.e. heated tobacco products, hand-rolled cigarettes, cigarillos, cigars, pipes, snuff tobacco, chewing tobacco, etc.) within one week before screening
- Pregnant or lactating women or women who may be pregnant
- Subjects who have positive test result of SARS-CoV-2 test by the time of admission on Day-2
- Employed by the tobacco industries, CRO or clinical facility
etc.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
JAPAN TOBACCO INC.
Division name
Scientific and Regulatoly Affairs, Tobacco Business Headquarters
Zip code
105-6927
Address
4-1-1, Toranomon, Minato-ku, Tokyo
TEL
080-8131-5689
naoki.miura@jt.com
Public contact
Name of contact person
| 1st name | Danting |
| Middle name | |
| Last name | Huangfu |
Organization
JAPAN TOBACCO INC.
Division name
Scientific Regulatoly Affairs, Tobacco Business Headquarters
Zip code
105-6927
Address
4-1-1, Toranomon, Minato-ku, Tokyo
TEL
080-1040-2819
Homepage URL
danting.huangfu@jt.com
Sponsor or person
Institute
JAPAN TOBACCO INC.
Institute
Department
Personal name
Funding Source
Organization
JAPAN TOBACCO INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakata Clinic Institutional Review Board
Address
6-18, Tenyamachi, hakata-ku, Fukuoka-shi, Fukuoka prefecture
Tel
092-283-7701
miyako-koga@lta-med.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37680118/
Number of participants that the trial has enrolled
90
Results
Switching from cigarette smoking to DT3.0a, THS, and mDT3.0a showed significant exposure reductions in most of the selected HPHCs as compared to continuing smoking cigarettes, with reductions being similar in magnitude to reductions observed with smoking cessation.
Results date posted
| 2023 | Year | 10 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no notable differences in subject characteristics between any of the six groups, including age, sex, BMI, the tar values of the subject's usual brand of cigarettes, daily cigarette consumption per day, and the Fagerstrom Test for Nicotine Dependence score.
Participant flow
In total, 289 participants were screened, and 92 subjects were enrolled into the study. Two of these subjects discontinued the study before the exposure assessment period started. The remaining 90 subjects (15 in each study group) completed the study, either with use of investigational tobacco products or as part of the SS group according to assignment.
Adverse events
No exposure period AEs were reported in the study. Before the exposure assessment period, mild AEs(headache, vomiting and nausea) occurred in 1 subject and all AEs were resolved during the day. There were no other AEs, no clinically significant abnormalities in clinical and physiological laboratory values, or any deaths or serious AEs in the study.
Outcome measures
The difference of biomarkers of exposure to selected smoke constituents between the investigational groups
Plan to share IPD
No plans to share
IPD sharing Plan description
No plans to share
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 30 | Day |
Last modified on
| 2023 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051745
