UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Treatment Response and Quality of Life of Esomeprazole for Reflux Esophagitis Patients
Acronym	Evaluation of Treatment Response and Quality of Life of Esomeprazole for Reflux Esophagitis Patients
Scientific Title	Evaluation of Treatment Response and Quality of Life of Esomeprazole for Reflux Esophagitis Patients
Scientific Title:Acronym	Evaluation of Treatment Response and Quality of Life of Esomeprazole for Reflux Esophagitis Patients
Region	Japan

Condition
Condition	Reflux Esophagitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to evaluate treatment response and quality of life of esomeprazole for reflux esophagitis patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate by GerdQ questionnaire 4, 8 weeks after administration of esomeprazole
Key secondary outcomes	Influence of CYP2C19 Polymorphism on esomaplazole responsiveness

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	esomeprazole 20mg/day for 8 weeks p.o.
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	The patient who is diagnosed as a reflux esophagitis and has been treated with PPI (expect for esomaprazole) for 4weeks, but GerdQ questionare shows insufficient therapeutic effect.
Key exclusion criteria	1,Patients with a history of hypersensitivity to the study drug. 2,Patients in the administration of atazanavir sulfate or a Rirupibirin hydrochloride. 3,Patients with confirmed gastric ulcer, duodenal ulcer by endoscopy. 4,Patients who have unstable merger liver, kidney, heart disease or serious medical conditions. 5,History of gastrointestinal tract resection or vagotomy. 6,Pregnancy and lactation. 7,Patients treated with esomeprazole 14 days before obtaining informed consent 8,Patient in need of administration of the following agents other than the study drug during the study period (Excluding test drug), histamine H2-receptor antagonist, prokinetics, gastric mucosal protection, anticholinergic drugs, antacids, antidepressants, anti-anxiety drugs, steroids, bisphosphonates. 9,Patients who judged unsuitable for research participation.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Hidemi Middle name Last name Goto
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	466-8560
Address	65 Tsurumai-cho,Showa-ku, Nagoya
TEL	052-744-2172
Email	hgoto@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Kohei Middle name Last name Funasaka
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	466-8560
Address	65 Tsurumai-cho,Showa-ku, Nagoya
TEL	052-744-2172
Homepage URL
Email	k-funa@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine, Department of Gastroentelorogy and Hepatology
Institute
Department

Funding Source
Organization	None
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	Nagoya University school of medicine
Address	65 Tsurumai-cho,Showa-ku, Nagoya
Tel	052-744-2423
Email	ethics@med.nagoya-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

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 07 Day

Related information
URL releasing protocol	None
Publication of results	Unpublished

Result
URL related to results and publications	None
Number of participants that the trial has enrolled	3
Results	Because of the difficulty for gathering a new registration, we unfortunately decided to discontinue this study.
Results date posted	2022 Year 07 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	None
Participant flow	None
Adverse events	None
Outcome measures	None
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 09 Month 26 Day
Date of IRB	2013 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 27 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2014 Year 07 Month 01 Day
Last modified on	2022 Year 07 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012765