UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033732 |
|---|---|
| Receipt number | R000038471 |
| Scientific Title | Pharmacological examination of placebo effect in the brain |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2018/08/13 15:08:58 |
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Basic information
Public title
Pharmacological examination of placebo effect
in the brain
Acronym
Pharmacological examination of placebo effect
in the brain
Scientific Title
Pharmacological examination of placebo effect
in the brain
Scientific Title:Acronym
Pharmacological examination of placebo effect
in the brain
Region
| Japan |
Condition
Condition
functional gastrointestinal disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the placebo mechanism in the brain of functional gastrointestinal disorders by pharmacological examination
Basic objectives2
Others
Basic objectives -Others
Mechanism study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The role of dopaminergic in placebo effect in functional gastrointestinal disorders and controls.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
gastrointestinal distention
Interventions/Control_2
gastrointestinal distention and placebo
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
70 patients with functional gastrointestinal disorders diagnosed by ROME III criteria and 70 healthy controls
Key exclusion criteria
Surgical history
Allergy (food, drug)
Medical treatment in progress
During pregnancy and breast-feeding
With embedded metal
Phobia such as confinement, dark place, tip
BMI is outside the normal range (18.5 to 25)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiko Kano |
Organization
Frontier Research Institute for Interdisciplinary Science
Division name
Creative interdisciplinary research division
Zip code
Address
2-1 Seiryo, Aoba, Sendai, Japan
TEL
+81(0)22-717-8218
mkano@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Kano |
Organization
Frontier Research Institute for Interdisciplinary Science
Division name
Creative interdisciplinary research division
Zip code
Address
2-1 Seiryo, Aoba, Sendai, Japan
TEL
+81(0)22-717-8218
Homepage URL
mkano@med.tohoku.ac.jp
Sponsor or person
Institute
Frontier Research Institute for Interdisciplinary Science
Institute
Department
Personal name
Funding Source
Organization
Creative interdisciplinary research division
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 09 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | 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
| 2018 | Year | 08 | Month | 13 | Day |
Last modified on
| 2018 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038471
