UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of acotiamide on esophageal motility and EGJ distensibility for gastroesophageal reflux disease.
Title of the study (Brief title)	effets of acotiamide for GERD
Region	Japan

Condition
Condition	GERD
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is examination in esophageal motor function and distensibility of the esophagogastric junction after administration of acotiamide to GERD patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in esophageal motor function and distensibility of the esophagogastric junction after administration of acotiamide 300 mg / day for 3 days and after the last dose 2 hours.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Acotiamide 300 mg / day for 3 days
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	GERD patients
Key exclusion criteria	Post operation of esophagus
Target sample size	10

Research contact person
Name of lead principal investigator	Hironobu Mikami
Organization	Shimane University Faculty of Medicine
Division name	Second Department of Internal Medicine
Address	89-1, Enya-cho, Izumo, Shimane, Japan
TEL	0853-20-2190
Email	d_h_m202@yahoo.co.jp

Public contact
Name of contact person	Hironobu Mikami
Organization	Shimane University Faculty of Medicine
Division name	Second Department of Internal Medicine
Address	89-1, Enya-cho, Izumo, Shimane, Japan
TEL	0853-20-2190
Homepage URL
Email	d_h_m202@yahoo.co.jp

Sponsor
Institute	Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization	Second Department of Internal Medicine, Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization	Other
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	2018 Year 05 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 01 Day
Last modified on	2018 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036989