UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Current status of functional dyspepsia treatment in Kurashiki district -multicener collaborative research-
Title of the study (Brief title)	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	Manabe Noriaki
Organization	Kawasaki Medical School
Division name	Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Address	577 Matsushima, Kurashiki
TEL	086-462-1111
Email	n_manabe@hkg.odn.ne.jp

Public contact
Name of contact person	Manabe Noriaki
Organization	Kawasaki Medical School
Division name	Division of Endoscopy and Ultrasonography
Address	577 Matsushima, Kurashiki
TEL	086-462-1111
Homepage URL
Email	n_manabe@hkg.odn.ne.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028846