UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021786 |
|---|---|
| Receipt number | 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 15:38:36 |
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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
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
momomau@aichi-med-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology Department of Internal Medicine Aichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019559
