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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000033648
Receipt No. R000030684
Official scientific title of the study Clinical factors related with symptoms in patients with GERD
Date of disclosure of the study information 2018/08/10
Last modified on 2018/08/06

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Basic information
Official scientific title of the study Clinical factors related with symptoms in patients with GERD
Title of the study (Brief title) GERD stmptoms and gastrin levels
Region
Japan

Condition
Condition reflux esophagitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinical factors including gastrin levels related with GERD symptoms
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between serum gastrin levels and F scale total scores
Key secondary outcomes Correlation between serum gastrin levels and F scale GERD score or motility scores
Other factors including serum pepsinogen levels and known GERD risk factors, such as H. pylori infections, atrophic scores, hiatus hernia etc.

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 Patients taking PPI
Key exclusion criteria GI bleeding, nausea, malignant lesions
history of gastrectomy, IBS, Renal failure, severe hepatic, renal, cardica dseases, taking NSAIDs, LDA, other antitrombotics, malignant anemia
Target sample size 600

Research contact person
Name of lead principal investigator Akiko Shiotani
Organization Kawasaki Medical School
Division name Internal Medicine Division of Gastroenterology
Address 577 matsushima Kurashiki city
TEL 0874721111
Email shiotani@med.kawasaki-m.ac.jp

Public contact
Name of contact person Akiko Shiotani
Organization Kawasaki Medical School
Division name Internal Medicine Division of Gastroenterology
Address 577 matsushima Kurashiki city
TEL 0874721111
Homepage URL
Email shiotani@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Astra Zeneca
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 08 Month 10 Day

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 06 Month 30 Day
Anticipated trial start date
2018 Year 07 Month 01 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 Just start entry

Management information
Registered date
2018 Year 08 Month 06 Day
Last modified on
2018 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030684

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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