UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022301 |
|---|---|
| Receipt number | R000025638 |
| Scientific Title | Observational study of placebo effect for a variable factor between individuals-reactive character mediated serotonin transporter genotype |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2016/05/13 14:13:37 |
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Basic information
Public title
Observational study of placebo effect for a variable factor between individuals-reactive character mediated serotonin transporter genotype
Acronym
placebo effect for a variable factor between individuals
Scientific Title
Observational study of placebo effect for a variable factor between individuals-reactive character mediated serotonin transporter genotype
Scientific Title:Acronym
placebo effect for a variable factor between individuals
Region
| Japan |
Condition
Condition
Hearthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Observational study of placebo effect for a variable factor between individuals - reactive character mediated serotonin transporter genotyp
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Finding of responders and non-responders for placebo effect by gene polymorphism of serotonine trasporter
Key secondary outcomes
Finding of cognitive indicator of placebo reaction by brain prefrontal cortex activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
placebo drug (lactose)
Interventions/Control_2
caffine
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
Participants who Candidates received a doctor's examination and physical examination(height, weight, temperature, and blood pressure)
Key exclusion criteria
Participants are selected by doctor
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Emi Nakashima |
Organization
Faculty of Pharmacy, Keio University
Division name
Division of Pharmaceutics
Zip code
Address
1-5-30, Shibako-en, Minato-ku, Tokyo
TEL
03-5400-2660
nakashima-em@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 Pharmaceutics
Zip code
Address
1-5-30, Shibako-en, Minato-ku, Tokyo
TEL
03-5400-2660
Homepage URL
isawa-mn@pha.keio.ac.jp
Sponsor or person
Institute
Faculty of Pharmacy, Keio University
Division of Pharmaceutics
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research from Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 08 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 13 | Day |
Last modified on
| 2016 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025638
