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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025777
Receipt No. R000029641
Scientific Title A study to evaluate the exposure to selected smoke constituents in healthy smokers using B-003 for 5 days confined in a hospital
Date of disclosure of the study information 2017/12/15
Last modified on 2018/11/13

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Basic information
Public title A study to evaluate the exposure to selected smoke constituents in healthy smokers using B-003 for 5 days confined in a hospital
Acronym A study to evaluate the exposure to selected smoke constituents when using B-003
Scientific Title A study to evaluate the exposure to selected smoke constituents in healthy smokers using B-003 for 5 days confined in a hospital
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuyuki Futamura
Organization JAPAN TOBACCO INC.
Division name Scientific product assessment center, Tobacco Business Headquarters
Zip code
Address 6-2, Umegaoka, Aoba-ku, Yokohama, Kanagawa
TEL 045-345-5222
Email yasuyuki.futamura@jt.com

Public contact
Name of contact person
1st name
Middle name
Last name Kyoko Nakaya
Organization JAPAN TOBACCO INC.
Division name Scientific product assessment center, Tobacco Business Headquarters
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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