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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029915
Receipt No. R000034173
Scientific Title Individual change factors for placebo reaction:Study of placebome and personality trait
Date of disclosure of the study information 2017/11/30
Last modified on 2018/05/28

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Basic information
Public title Individual change factors for placebo reaction:Study of placebome and personality trait
Acronym Individual change factors for placebo reaction
Scientific Title Individual change factors for placebo reaction:Study of placebome and personality trait
Scientific Title:Acronym Individual change factors for placebo reaction
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Study of genetic polymorphism and personality trait for placebo reaction
Basic objectives2 Others
Basic objectives -Others effect of placebo
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes subjective indicator:Stanford sleepiness scale(SSS),Visual analogue scale
objective indicator:serotonin transporter polymorphic, catechol-o-transferase transporter polymorphic
Key secondary outcomes subjective indicator:Stanford sleepiness ssubjective indicator Personality examination
objective indicator:blood flow of Brain prefrontal area

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 placebo administration(lactose), single dose
Interventions/Control_2 placebo administration(lactose), single dose
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
35 years-old >=
Gender Male and Female
Key inclusion criteria Healthy subjects
Key exclusion criteria intreatment, subjects with allergy for drugs and foods
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mayumi Mochizuki
Organization Faculty of pharmacy, Keio university
Division name Division of Hospital Pharmacy Science
Zip code
Address 1-5-30, Shibakoen, Minato-ku, Tokyo, Japan
TEL 03-5400-2796
Email Mochizuki-my@pha.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minae Isawa
Organization Faculty of pharmacy, Keio university
Division name Division of Hospital Pharmacy Science
Zip code
Address 1-5-30, Shibakoen, Minato-ku, Tokyo, Japan
TEL 03-5400-2796
Homepage URL
Email isawa-mn@pha.keio.ac.jp

Sponsor
Institute Keio university hospital
Department of Neuropsychiatry, Keio University school of Medicine
Institute
Department

Funding Source
Organization Grants-in-Aid for scientific Research
Organization
Division
Category of Funding Organization Government offices of other countries
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 慶應義塾大学付属病院

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 30 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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 20 Day
Last follow-up date
2018 Year 06 Month 08 Day
Date of closure to data entry
2018 Year 06 Month 17 Day
Date trial data considered complete
2018 Year 06 Month 18 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 10 Day
Last modified on
2018 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034173

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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