UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Funaki Yasushi
Organization	Department of Intermal Medicine Aichi Medical University
Division name	Division of Gastroenterology
Address	1-1Yazakokarimata,Nagakute,Aichi
TEL	0561-62-3311
Email	momomaru@aichi-med-u.ac.jp

Public contact
Name of contact person	Funaki Yasushi
Organization	Department of Intermal Medicine Aichi Medical University
Division name	Division of Gastroenterology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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