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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014449
Receipt No. R000012765
Scientific Title Evaluation of Treatment Response and Quality of Life of Esomeprazole for Reflux Esophagitis Patients
Date of disclosure of the study information 2014/07/07
Last modified on 2018/07/24

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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
Middle name
Last name Hidemi Goto
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
Middle name
Last name Kohei Funasaka
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 07 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
Because of the difficulty for gathering a new registration, we unfortunately decided to discontinue this study. 
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 Open public recruiting
Date of protocol fixation
2013 Year 09 Month 26 Day
Date of IRB
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
2018 Year 07 Month 24 Day


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

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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