Unique ID issued by UMIN | UMIN000049840 |
---|---|
Receipt number | R000056768 |
Scientific Title | A Cross-sectional Observational Study in Japan to Investigate Biological Effect Associated with the Use of Ploom X |
Date of disclosure of the study information | 2022/12/27 |
Last modified on | 2023/08/08 11:12:24 |
A Cross-sectional Observational Study in Japan to Investigate Biological Effect Associated with the Use of Ploom X
A Cross-sectional Observational Study in Japan to Investigate Biological Effect Associated with the Use of Ploom X
A Cross-sectional Observational Study in Japan to Investigate Biological Effect Associated with the Use of Ploom X
A Cross-sectional Observational Study in Japan to Investigate Biological Effect Associated with the Use of Ploom X
Japan |
Tobacco Product Users and Never smokers
Not applicable |
Others
NO
To investigate exposure to selected smoke constituents and biological effect in Ploom X users
Others
- To investigate the levels of biomarker of exposure to selected smoke constituents and biomarkers of potential harm in Ploom X users relative to cigarette smokers and never smokers
- To investigate the level of cough in Ploom X users relative to cigarette smokers and never smokers
The difference of biomarker of exposure and biomarkers of potential harm in Ploom X users relative to cigarette smokers and never smokers
The difference of the level of cough in Ploom X users relative to cigarette smokers and never smokers
Observational
30 | years-old | <= |
65 | years-old | > |
Male and Female
- Subjects who sign the study-specific consent form
- Ploom X user: Subjects who use Ploom X exclusively more than three months
- Cigarette smoker: Subjects who smoke cigarettes exclusively more than one year
- Never smoker: Subjects who have never used tobacco products and nicotine containing products
etc.
- Subjects who have, or who have a history of, any clinically significant cardiovascular, hepatic, renal, hematological, respiratory, endocrine, metabolic, electrolyte imbalance
- Subjects who have received any investigational drug within 4 months prior to the study period
- Pregnant or lactating women or women who may be pregnant
- Subjects who have positive test result of SARS-CoV-2 test at screening
- Subjects who are employed in the tobacco industries, CRO or clinical facility
etc.
500
1st name | Naoki |
Middle name | |
Last name | Miura |
JAPAN TOBACCO INC.
Scientific and Regulatory Affairs, Tobacco Business
105-6927
Kamiyacho Trust tower, 4-1-1, Toranomon, Minato-Ku, Tokyo
080-8131-5689
naoki.miura@jt.com
1st name | Chikako |
Middle name | |
Last name | Sakaguchi |
JAPAN TOBACCO INC.
Scientific and Regulatory Affairs, Tobacco Business
105-6927
Kamiyacho Trust tower, 4-1-1, Toranomon, Minato-Ku, Tokyo
080-2191-1784
chikako.sakaguchi@jt.com
JAPAN TOBACCO INC.
None
Self funding
Hakata Clinic Institutional Review Board
6-18, Tenyamachi, hakata-ku, Fukuoka-shi, Fukuoka prefecture
092-283-7701
miyako-koga@lta-med.com
NO
2022 | Year | 12 | Month | 27 | Day |
Unpublished
Completed
2022 | Year | 11 | Month | 29 | Day |
2022 | Year | 12 | Month | 15 | Day |
2023 | Year | 02 | Month | 02 | Day |
2023 | Year | 06 | Month | 19 | Day |
This is a cross-sectional observational study of a heated tobacco product to investigate biomarkers of exposure and potential harm, and levels of cough in Ploom X users relative to cigarette smokers and non-smokers.
2022 | Year | 12 | Month | 20 | Day |
2023 | Year | 08 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056768
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