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Recruitment status
Unique ID issued by UMIN UMIN000021786
Receipt No. R000019559
Scientific Title Study of gastroesophageal reflux disease (GERD) patients with esophageal motor disorder using High resolution manometry (HRM)
Date of disclosure of the study information 2016/04/06
Last modified on 2016/04/05

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Basic information
Public title Study of gastroesophageal reflux disease (GERD) patients with esophageal motor disorder using High resolution manometry (HRM)
Acronym Study of gastroesophageal reflux disease (GERD) patients with esophageal motor disorder using High resolution manometry (HRM)
Scientific Title Study of gastroesophageal reflux disease (GERD) patients with esophageal motor disorder using High resolution manometry (HRM)
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Yasushi Funaki
Organization Aichi Medical University
Division name Division of Gastroenterology
Zip code
Address 1-1Yazakokarimata,Nagagute,Aichi,Japan
TEL 0561-62-3311
Email momomau@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Funaki
Organization Aichi Medical University
Division name Division of Gastroenterology
Zip code
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

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)

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 04 Month 06 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
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
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

Other
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-open-bin/ctr_e/ctr_view.cgi?recptno=R000019559

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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