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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010360
Receipt No. R000012118
Scientific Title Influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on mental calculations, blood pressure and pulse rate after intake of caffeine: a double-blind randomized placebo-controlled clinical trial.
Date of disclosure of the study information 2013/04/01
Last modified on 2017/09/19

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Basic information
Public title Influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on mental calculations, blood pressure and pulse rate after intake of caffeine: a double-blind randomized placebo-controlled clinical trial.
Acronym Influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on the effect of caffeine
Scientific Title Influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on mental calculations, blood pressure and pulse rate after intake of caffeine: a double-blind randomized placebo-controlled clinical trial.
Scientific Title:Acronym Influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on the effect of caffeine
Region
Japan

Condition
Condition Effect of caffeine
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To reveal the influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on effect of caffeine 200 mg on mental calculation ability, blood pressure and pulse rate.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Change of the accurate number of mental calculation after intake caffeine 200 mg compared to decafe
Key secondary outcomes Change of blood pressure and pulse rate after intake caffeine 200 mg compared to decafe

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 intake coffee 150 mL with caffeine 200mg
Interventions/Control_2 intake coffee 150 mL without caffeine
Interventions/Control_3
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adult volunteers
Key exclusion criteria 1. cardiovascular disease that should be treated
2. severe liver disease
3. severe renal disease
4. pregnant women and women suspected of being pregnant
5. severe allergic reaction and allergic reaction to caffeine
6. gastric ulcer
7. glaucoma
8. On medical treatment
9. Not appropriate to this study by other reasons
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Sasaguri
Organization Faculty of Medical Science, Kyushu University
Division name Department of Clinical Pharmacology
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka
TEL +81-92-642-6082
Email sasaguri@clipharm.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Yoshihara
Organization Faculty of Medical Sciences, Kyushu University
Division name Department of Clinical Pharmacology
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka
TEL +81-92-642-6082
Homepage URL
Email tatsuya@clipharm.med.kyushu-u.ac.jp

Sponsor
Institute Department of Clinical Pharmacology, Faculty of Medical Science, Kyushu University
Institute
Department

Funding Source
Organization Self funding
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
2013 Year 04 Month 01 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
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 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
2013 Year 03 Month 29 Day
Last modified on
2017 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012118

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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