UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of Gastric motility in Functional dyspepsia and Healthy control
Title of the study (Brief title)	Gastric motility in Functional dyspepsia
Region	Japan

Condition
Condition	Healthy volunteer and functional dyspepsia(FD)
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	analysis of gastric motility using HRM
Basic objectives2	Others
Basic objectives -Others	Change of gastric motility by treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysis of gastric motility in healthy volunteer and FD. Change of gastric motility in FD after treatment.
Key secondary outcomes	Correlation between gastric motility and symptom

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	acotiamide administration for FD
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Diagnosis of FD by Rome3 criteria GOS>=4 in one ofthe questionnaire item age of >=20 Obtaine IC by document asymptomatic case is enrolled as healthy control
Key exclusion criteria	Less than 1 year from H.pylori eradication Took anti-acid medicine within 1 week Took acotiamide within 4 weeks drug allergy severe concomitant disease
Target sample size	20

Research contact person
Name of lead principal investigator	Akihito Nagahara
Organization	Juntendo University School of medicine
Division name	Gastroenterology
Address	2-1-1 Hongo Bunkyo-ku Tokyo
TEL	03-3813-3111
Email	nagahara@juntendo.ac.jp

Public contact
Name of contact person	Akihito Nagahara
Organization	Juntendo University School of medicine
Division name	Gastroenterology
Address	2-1-1 Hongo Bunkyo-ku Tokyo
TEL	03-3813-3111
Homepage URL
Email	nagahara@juntendo.ac.jp

Sponsor
Institute	Gastroenterology Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	Grants-in-aid for scientific resarch
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 12 Month 05 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 11 Month 21 Day
Anticipated trial start date	2014 Year 11 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 05 Day
Last modified on	2017 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017740