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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name