UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025079
Receipt number R000028846
Scientific Title Current status of functional dyspepsia treatment in Kurashiki district -multicener collaborative research-
Date of disclosure of the study information 2016/11/30
Last modified on 2018/09/10 11:05:45

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Basic information

Public title

Current status of functional dyspepsia treatment in Kurashiki district -multicener collaborative research-

Acronym

Kurashiki FD study

Scientific Title

Current status of functional dyspepsia treatment in Kurashiki district -multicener collaborative research-

Scientific Title:Acronym

Kurashiki FD study

Region

Japan


Condition

Condition

Functional gastrointestinal disorders

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effective of treatment

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Improve subjective symptoms

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Treatment with PPI takes 2 weeks

Interventions/Control_2

Treatment with acotiamide for 2 weeks

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Functional dyspepsia

Key exclusion criteria

Patients who has organic, systemic, metabolism disease, and history of post abdominal surgery. Patients who are using aspirin or NSAIDs, and pregnant. Patients who refused conent.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Manabe Noriaki

Organization

Kawasaki Medical School

Division name

Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine

Zip code


Address

577 Matsushima, Kurashiki

TEL

086-462-1111

Email

n_manabe@hkg.odn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Manabe Noriaki

Organization

Kawasaki Medical School

Division name

Division of Endoscopy and Ultrasonography

Zip code


Address

577 Matsushima, Kurashiki

TEL

086-462-1111

Homepage URL


Email

n_manabe@hkg.odn.ne.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

Organization

Division

Category of Funding Organization

Self funding

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

2016 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

Terminated

Date of protocol fixation

2016 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 12 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

2016 Year 11 Month 30 Day

Last modified on

2018 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028846


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name