UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004334 |
|---|---|
| Receipt number | R000005191 |
| Scientific Title | A study of the changes of biomarkers for A-803 in healthy adult male smokers |
| Date of disclosure of the study information | 2011/12/31 |
| Last modified on | 2012/01/05 10:40:16 |
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Basic information
Public title
A study of the changes of biomarkers for A-803 in healthy adult male smokers
Acronym
A biomarker study for A-803
Scientific Title
A study of the changes of biomarkers for A-803 in healthy adult male smokers
Scientific Title:Acronym
A biomarker study for A-803
Region
| Japan |
Condition
Condition
Smokers, nonsmokers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the change of biomarkers of effect by the use of test cigarettes for smokers
Basic objectives2
Others
Basic objectives -Others
To investigate the change of biomarkers of exposure for smokers and to investigate the non tobacco-specific factors on biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the change of biomarkers of effect in healthy adult male smokers during four-week use of A-803 in comparison with a conventional tobacco product
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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 usual cigarette brand (for two days) => Use of A-803 (for twenty-eight days)
Interventions/Control_2
<Smokers> Use of subject's usual cigarette brand (for two days) => Use of a conventional tobacco product (for twenty-eight days)
Interventions/Control_3
<Nonsmokers> No tobacco product use
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
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1. Subjects who sign the study-specific consent form
2. Subjects who are confirmed to be in good health through the screening process
3. For smokers, subjects who do not plan to quit smoking over the study period
4. For nonsmokers, subjects who do not plan to use tobacco products over the study period
etc.
Key exclusion criteria
1. Subjects who have regular use experience of hand-rolled cigarette, cigarillo, cigar, pipe, smokeless tobacco or chewing tobacco
2. Subjects who donate 200ml or more of blood within 4 weeks before screening, or who donate 400ml or more of blood within 12 weeks before screening (including blood donation)
etc.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Moriyama |
Organization
JAPAN TOBACCO INC.
Division name
Product Science Division, R&D Group, Tobacco Business Headquarters
Zip code
Address
1-17-7, Yokokawa, Sumida-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
JAPAN TOBACCO INC.
Division name
Product Science Division, R&D Group, Tobacco Business Headquarters
Zip code
Address
1-17-7, Yokokawa, Sumida-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
JAPAN TOBACCO INC.
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2011 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2010 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2012 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005191
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
