UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the exposure to selected smoke constituents in healthy smokers using B-003 for 5 days confined in a hospital
Title of the study (Brief title)	A study to evaluate the exposure to selected smoke constituents when using B-003
Region	Japan

Condition
Condition	Smokers
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the exposure to selected smoke constituents in smokers switching to B-003 confined in a hospital
Basic objectives2	Others
Basic objectives -Others	To investigate the exposure to selected smoke constituents in smokers using their own brands of comercial cigarettes or abstaining from smoking confined in a hospital
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The difference of biomarkers of exposure to selected smoke constituents between the investigational tobacco products
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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	(Smokers) Use of subject's own brand for 2 days (confined in a hospital) Use of B-003 for 5 days (confined in a hospital)
Interventions/Control_2	(Smokers) Use of subject's own brand for 2 days (confined in a hospital) Continued use of of subject's own brand for 5 days (confined in a hospital)
Interventions/Control_3	(Smokers) Use of subject's own brand for 2 days (confined in a hospital) Abstinence from smoking for 5 Days (confined in a hospital)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
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 Subjests who are confirmed to be in good health from all of the inspection results Smokers etc.
Key exclusion criteria	Subjects who have used tobacco products other than commercial cigarettes (i.e.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 etc.
Target sample size	60

Research contact person
Name of lead principal investigator	Yasuyuki Futamura
Organization	JAPAN TOBACCO INC.
Division name	Scientific product assessment center, Tobacco Business Headquarters
Address	6-2, Umegaoka, Aoba-ku, Yokohama, Kanagawa
TEL	045-345-5222
Email	yasuyuki.futamura@jt.com

Public contact
Name of contact person	Kyoko Nakaya
Organization	JAPAN TOBACCO INC.
Division name	Scientific product assessment center, Tobacco Business Headquarters
Address	6-2, Umegaoka, Aoba-ku, Yokohama, Kanagawa
TEL	045-345-5150
Homepage URL
Email	kyoko.nakaya@jt.com

Sponsor
Institute	JAPAN TOBACCO INC.
Institute
Department

Funding Source
Organization	JAPAN TOBACCO INC.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 30 Day
Anticipated trial start date	2017 Year 01 Month 21 Day
Last follow-up date	2017 Year 02 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 20 Day
Last modified on	2018 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029641