UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation of symptom and pathophysiological changes after 20mg of esomeprazole administration by 24-hour intraesophageal pH/impedance (MII-pH) monitoring.
Acronym	The evaluation of symptom and pathophysiological changes after esomeprazole administration by impedance monitoring.
Scientific Title	The evaluation of symptom and pathophysiological changes after 20mg of esomeprazole administration by 24-hour intraesophageal pH/impedance (MII-pH) monitoring.
Scientific Title:Acronym	The evaluation of symptom and pathophysiological changes after esomeprazole administration by impedance monitoring.
Region	Japan

Condition
Condition	PPI-resistant gastro-esophageal reflux disease
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the symptom and pathophysiological changes by esomeprazole, PPI-resistant GERD patients are administrated esmeprazole instead of other PPIs and evaluate the symptom and pathophysiological changes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	symptom, QOL, neurosis evaluation by questionnaire
Key secondary outcomes	pathophysiology of GERD by 24-hour intraesophageal pH/impedance monitoring, HP infection, gastric mucosal atropy, CYP2C19 genetic polymorphism

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The subjects take 20 mg of esomeprazole once a day for four weeks.
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	(1) The study is conducted with the written informed consent of patients who had been given a full explanation of the study. (2)The GERD patients who has taken standard dose PPIs for 8 weeks. (3)The patients who was judged to be insufficient therapeutic response by GerdQ questionnaire.
Key exclusion criteria	(1)alarm sign such as vomitting or gastrointestinal bleeding (2)Zollinger Ellison syndrome, esophageal stenosis, achalasia, cerebrovascular disorder (3)Serious hepatic disorder, renal disease, heart disorder (4)malignant disorder (5)A pregnant woman, nursing mother or the woman who may be pregnant. (6)In addition, clinical studies supervisor or the study attending physician judged the subject to be inadequate to attend this study.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kunio Middle name Last name Kasugai
Organization	Aichi Medical University School of Medicine
Division name	Gastroenterology
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
TEL	0561-62-3311
Email	kuku3487@aichi-med-u.ac.jp

Public contact
Name of contact person	1st name Kunio Middle name Last name Kasugai
Organization	Aichi Medical University School of Medicine
Division name	Gastroenterology
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
TEL	0561-62-3311
Homepage URL
Email	kuku3487@aichi-med-u.ac.jp

Sponsor
Institute	Division of Gastroenterology, Aichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Research Organization for GastroEnterological Disease Treatment
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	non
Name of secondary funder(s)	non

IRB Contact (For public release)
Organization	Aichi Medical University School of Medicine
Address	1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
Tel	0561-62-3311
Email	syomu@aichi-med-u.ac.jp

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	2012 Year 11 Month 10 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	Completed
Date of protocol fixation	2012 Year 05 Month 01 Day
Date of IRB	2012 Year 05 Month 30 Day
Anticipated trial start date	2012 Year 05 Month 30 Day
Last follow-up date	2016 Year 04 Month 30 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded	2016 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date	2012 Year 11 Month 05 Day
Last modified on	2019 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010866