UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the patient satisfaction in the self-reporting-questionnaire after the switching PPI from existing PPI to Esomeprazole in the reflux esophagitis patients
Title of the study (Brief title)	Study of the patient satisfaction in a self-reporting-questionnaire after the Esomeprazole switching
Region	Japan

Condition
Condition	GERD
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Some reflux esophagitis patients remain with GERD symptom in spite of PPI treatment, and there are many patients who are not fully satisfied. Therefore, we switch PPI from other PPI to Esomeprazole for the RE patients who have GERD symptoms despite being administered other PPI, and we evaluate the change of the symptoms, the satisfaction level of patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of patient satisfaction in a self-reporting-questionnaire
Key secondary outcomes	Comparison of the effect according to the background factor

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	Esomeplazole 20mg
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	Patient who fills everything the following 1) Man or woman who is 20 years old or older at the time of getting informed consent 2) Patient whom is given existing PPI, but one of the heartburn or acid reflux symptoms remains in 3) Patient that a document informed consent by the free intention of patients was gotten on enough understanding after having received enough explanation on participating in this study
Key exclusion criteria	The patient in conflict with the following exclusion criteria is not enrolled 1) Patient with the drug allergy 2) Patient who complicated a serious heart disease, serious liver disease, renal function disorder, and malignant tumor
Target sample size	50

Research contact person
Name of lead principal investigator	Masahiko Inamori
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Address	3-9 Fukuura, Kanagawa-ku, Yokohama, Japan
TEL	045-787-2800
Email

Public contact
Name of contact person	Masahiko Inamori
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Address	3-9 Fukuura, Kanagawa-ku, Yokohama, Japan
TEL	045-787-2800
Homepage URL
Email

Sponsor
Institute	Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 27 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

Management information
Registered date	2013 Year 05 Month 27 Day
Last modified on	2017 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012650