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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030317
Receipt No. R000034621
Scientific Title Related examination of the serum gastrin level of patients with gastroesophageal reflux disease in the acid-secreting suppressant administration treatment and the intragastric acid kinetics of secretion
Date of disclosure of the study information 2017/12/08
Last modified on 2017/12/08

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Basic information
Public title Related examination of the serum gastrin level of patients with gastroesophageal reflux disease in the acid-secreting suppressant administration treatment and the intragastric acid kinetics of secretion
Acronym Related examination of the serum gastrin level of patients with gastroesophageal reflux disease in the acid-secreting suppressant administration treatment and the intragastric acid kinetics of secretion
Scientific Title Related examination of the serum gastrin level of patients with gastroesophageal reflux disease in the acid-secreting suppressant administration treatment and the intragastric acid kinetics of secretion
Scientific Title:Acronym Related examination of the serum gastrin level of patients with gastroesophageal reflux disease in the acid-secreting suppressant administration treatment and the intragastric acid kinetics of secretion
Region
Japan

Condition
Condition The acid-secreting suppressant-resistant GERD patients
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the association of the ratio in patients with treated gastroesophageal reflux disease eight weeks or more with PPI and P-CAB standard dose at under intragastric pH 4 time for serum gastrin level and 24 hours.
Basic objectives2 Others
Basic objectives -Others We perform 24pHMII for the purpose of gastroesophageal reflux dynamics associated with the onset of symptom of subjects and intragastric acid drying effect.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Serum gastrin level of the acid-secreting suppressant-resistant GERD patients
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria atients with GERD symptom survival that the patients who gastroesophageal reflux disease was diagnosed in this hospital, and received treatment eight weeks or more with PPI or P-CAB standard dose showed more than two points in GERDQ
Key exclusion criteria The patients with a history of the following disease or the patients who merge now
Zollinger -Ellison syndrome ,Oesophageal stenosis ,Serious esophagus dyskinesia including the achalasia symptom ,Cerebrovascular disorder such as cerebral hemorrhage, cerebral infarction. The Helicobacter pylori infection history patients.
The patients who have difficulty in participation in this study by a merger with serious hepatic disorder, renal disease, heart disorder .A malignant lesion was confirmed; or is the patients with suspected malignant lesion. A pregnant woman, nursing mother or the woman who may be pregnant .In addition, the patients who judged that clinical studies responsibility physician or the study medical attendant was inadequate
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Funaki Yasushi
Organization Department of Intermal Medicine Aichi Medical University
Division name Division of Gastroenterology
Zip code
Address 1-1Yazakokarimata,Nagakute,Aichi
TEL 0561-62-3311
Email momomaru@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Funaki Yasushi
Organization Department of Intermal Medicine Aichi Medical University
Division name Division of Gastroenterology
Zip code
Address 1-1Yazakokarimata,Nagakute,Aichi
TEL 0561-62-3311
Homepage URL
Email momomaru@aichi-med-u.ac.jp

Sponsor
Institute Department of Intermal Medicine Aichi Medical University
Institute
Department

Funding Source
Organization Department of Intermal 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 愛知医科大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 08 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information non

Management information
Registered date
2017 Year 12 Month 08 Day
Last modified on
2017 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034621

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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