UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of gastroesophageal reflux disease (GERD) patients with esophageal motor disorder using High resolution manometry (HRM)
Title of the study (Brief title)	Study of gastroesophageal reflux disease (GERD) patients with esophageal motor disorder using High resolution manometry (HRM)
Region	Japan

Condition
Condition	gastroesophageal reflux disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To diagnose the esophageal motor disorder and evaluate the clinical condition of GERD patients by HRM for applying GERD treatment
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	We analyze the clinical condition and the esophageal motor disorder.
Key secondary outcomes	Frequency of the esophageal motor disorder

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with gastroesophageal reflux disease without the organic disease
Key exclusion criteria	Serious complications
Target sample size	300

Research contact person
Name of lead principal investigator	Yasushi Funaki
Organization	Aichi Medical University
Division name	Division of Gastroenterology
Address	1-1Yazakokarimata,Nagagute,Aichi,Japan
TEL	0561-62-3311
Email	momomau@aichi-med-u.ac.jp

Public contact
Name of contact person	Yasushi Funaki
Organization	Aichi Medical University
Division name	Division of Gastroenterology
Address	1-1Yazakokarimata,Nagagute,Aichi,Japan
TEL	0561-62-3311
Homepage URL
Email	momomau@aichi-med-u.ac.jp

Sponsor
Institute	Division of Gastroenterology Department of Internal Medicine Aichi Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Division of Gastroenterology Department of Internal Medicine Aichi Medical University
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	2016 Year 04 Month 06 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 06 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	Evaluation of the esophagus function by the high-resolution

Management information
Registered date	2016 Year 04 Month 05 Day
Last modified on	2016 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000019559