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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032593
Receipt No. R000036675
Scientific Title The factors related with GI symptoms in patients with GERD
Date of disclosure of the study information 2018/06/01
Last modified on 2021/02/22

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Basic information
Public title The factors related with GI symptoms in patients with GERD
Acronym GI symptoms in GERD patients
Scientific Title The factors related with GI symptoms in patients with GERD
Scientific Title:Acronym GI symptoms in GERD patients
Region
Japan

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

Objectives
Narrative objectives1 To investigate association between symptoms of patients with reflux esophagitis (RE) and their factors in a cross-sectional manner.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the association between total score evaluated by F-scale and fasting blood gastrin level
Key secondary outcomes

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 1) People aged 20 or older who have provided written consent to participate in this study
2) RE patients under treatment with acid suppressants
Key exclusion criteria 1) Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia), or sudden weight loss
2) Patients with a confirmed or suspected malignant lesion
3) Patients with a history of gastrointestinal resection or vagotomy
4) Patients with irritable bowel syndrome
5) Hypergastrinemic patients with renal failure, ZE syndrome, etc
6) Patients complicated by serious hepatic, renal, cardiac, or other diseases
7) Patients on NSAIDs and low-dose aspirin
8) Patients with pernicious anemia
9) Other patients judged by their attending physicians to be inappropriate for this study
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Akiko
Middle name
Last name Shiotani
Organization Kawasaki Medical School
Division name Internal Medicine Division of Gastroenterology
Zip code 701-0192
Address 577 Matushima Kurasiki city Okayama 701-0192 Japan
TEL 0864621111
Email shiotani@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Shiotani
Organization Kawasaki Medical School
Division name Internal Medicine Division of Gastroenterology
Zip code 701-0192
Address 577 Matushima Kurasiki city Okayama 701-0192 Japan
TEL 0864621111
Homepage URL
Email shiotani@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization AstraZeneca
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kawasaki Medical School
Address 577 Matushima Kurasiki city Okayama 701-0192 Japan
Tel 0864621111
Email kmsrec@med.kawasaki-m.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
2018 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 311
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
2018 Year 05 Month 14 Day
Date of IRB
2020 Year 05 Month 24 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information non

Management information
Registered date
2018 Year 05 Month 14 Day
Last modified on
2021 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036675

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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