UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041539 |
|---|---|
| Receipt number | R000047425 |
| Scientific Title | A study to evaluate exposure to selected smoke constituents in healthy adult smokers using heated tobacco products for 5 days under clinical confinement |
| Date of disclosure of the study information | 2021/04/22 |
| Last modified on | 2023/02/15 13:50:23 |
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Basic information
Public title
A study to evaluate exposure to selected smoke constituents when using heated tobacco products
Acronym
A study to evaluate exposure to selected smoke constituents when using heated tobacco products
Scientific Title
A study to evaluate exposure to selected smoke constituents in healthy adult smokers using heated tobacco products for 5 days under clinical confinement
Scientific Title:Acronym
A study to evaluate exposure to selected smoke constituents in healthy adult smokers using heated tobacco products 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 commercially available heated tobacco products 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 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
<Smokers> Use of subject's own brand cigarette for 2 days (clinical confinement)-Use of heated tobacco product A for 5 days (clinical confinement)
Interventions/Control_2
<Smokers> Use of subject's own brand cigarette for 2 days (clinical confinement)-Use of heated tobacco product B for 5 days (clinical confinement)
Interventions/Control_3
<Smokers> Use of subject's own brand cigarette for 2 days (clinical confinement)-Use of heated tobacco product C for 5 days (clinical confinement)
Interventions/Control_4
<Smokers> Use of subject's own brand cigarette for 2 days (clinical confinement)-Use of heated tobacco product D for 5 days (clinical confinement)
Interventions/Control_5
<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_6
<Smokers> Use of subject's own brand cigarette for 2 days (clinical confinement) -Abstinence from smoking 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
-Employed by the tobacco industries, CRO or clinical facility
etc.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ishikawa |
Organization
JAPAN TOBACCO INC.
Division name
Scientific Regulatoly Affairs, Tobacco Business Headquarters
Zip code
105-8822
Address
2-2-1, Toranomon, Minato-ku, Tokyo
TEL
03-5572-4218
satoshi.ishikawa@jt.com
Public contact
Name of contact person
| 1st name | Chikako |
| Middle name | |
| Last name | Sakaguchi |
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
080-2191-1784
Homepage URL
chikako.sakaguchi@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 | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36307514/
Number of participants that the trial has enrolled
93
Results
On Day 5, significant reductions in most biomarkers of exposure (BoE) relative to the combustible cigarettes (CC) group were observed after switching to heated tobacco products. No changes in BoE were observed between baseline and Day 5 in the CC group. Significantly, the magnitude of the reduction in exposure to most of the selected harmful and potentially harmful constituents (HPHCs) observed in the heated tobacco product groups was close to that observed in the stopped smoking (SS) group.
Results date posted
| 2023 | Year | 02 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There was no substantial difference between any of the six groups in terms of age, sex, BMI, daily cigarette consumption, the tar values of the subject's usual brand of CC, and FTND score at screening.
Participant flow
Of the 252 participants screened, 93 subjects were enrolled into the study. During the baseline period, three subjects withdrew from the study for personal reasons or were withdrawn due to non-compliance with the randomization process. One subject who was assigned to the THP group withdrew on Day 1 for personal reasons and was excluded from the analysis because the subject did not have any BoE assessment after post-randomization. Thus, 89 subjects completed the study in accordance with
the protocol.
Adverse events
There were no AEs reported during the study.
Outcome measures
The difference of biomarkers of exposure to selected smoke constituents between the investigational groups
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 25 | Day |
Last modified on
| 2023 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047425
