UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048044 |
|---|---|
| Receipt number | R000046417 |
| Scientific Title | A study on the inter-individual variability of the nocebo effect |
| Date of disclosure of the study information | 2022/06/13 |
| Last modified on | 2024/10/24 16:38:42 |
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Basic information
Public title
A study on the inter-individual variability of the nocebo effect
Acronym
Individual change factors for nocebo reaction
Scientific Title
A study on the inter-individual variability of the nocebo effect
Scientific Title:Acronym
Individual change factors for nocebo 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 for nocebo reaction
Basic objectives2
Others
Basic objectives -Others
nocebo effects
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
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
fake drug administration(lactose), single dose
Interventions/Control_2
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
| 39 | 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
210
Research contact person
Name of lead principal investigator
| 1st name | Tohru |
| Middle name | |
| Last name | Aomori |
Organization
Faculty of pharmacy, Keio university
Division name
Division of Hospital Pharmacy Science
Zip code
105-8512
Address
1-5-30, Shibakoen, Minato-ku, Tokyo, Japan
TEL
03-5400-2486
aomori-th@pha.keio.ac.jp
Public contact
Name of contact person
| 1st name | Minae |
| Middle name | |
| Last name | Isawa |
Organization
Faculty of pharmacy, Keio university
Division name
Division of Hospital Pharmacy Science
Zip code
105-8512
Address
1-5-30, Shibakoen, Minato-ku, Tokyo, Japan
TEL
03-5400-2486
Homepage URL
isawa-mn@pha.keio.ac.jp
Sponsor or person
Institute
Keio university hospital
Department of Neuropsychiatry, Keio University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for scientific Research
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
Keio University School of Medical Ethics Board
Address
35 shinano-machi, sinjyuku-ku, tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
| 2022 | Year | 06 | Month | 13 | 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
0
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
Terminated
Date of protocol fixation
| 2022 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The clinical trial was cancelled
Management information
Registered date
| 2022 | Year | 06 | Month | 13 | Day |
Last modified on
| 2024 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046417
