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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014640
Receipt No. R000017033
Scientific Title Investigation of Reflux Esophagitis - Identifying factors predicting future onset of reflux esophagitis by examining changes over time in health examination data -
Date of disclosure of the study information 2014/07/24
Last modified on 2017/02/20

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Basic information
Public title Investigation of Reflux Esophagitis
- Identifying factors predicting future onset of reflux esophagitis by examining changes over time in health examination data -
Acronym Investigation to identify factors predicting future onset of reflux esophagitis based on health examination data
Scientific Title Investigation of Reflux Esophagitis
- Identifying factors predicting future onset of reflux esophagitis by examining changes over time in health examination data -
Scientific Title:Acronym Investigation to identify factors predicting future onset of reflux esophagitis based on health examination data
Region
Japan

Condition
Condition Reflux Esophagitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective is to determine factors for predicting future RE onset using health examination data and changes in these data over time determined by reviewing the examination data over the past 5 years of patients newly diagnosed with RE in a health examination (hereafter called "new RE patients") and comparing the data to the examination data over the past 5 years of a control population matched with the new RE patients in terms of sex, age, timing of testing, and institution.
Basic objectives2 Others
Basic objectives -Others Factors for predicting future RE onset
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) Differences in changes over time in the primary survey parameters between the patient group and control group over the 5-year period preceding RE diagnosis.
2) Differences in the values of the primary survey parameters at each time point between the patient group and control group at the time of RE diagnosis and over the 5-year period preceding RE diagnosis.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Case group: Patients aged >=30 with observation of RE onset based on endoscopic examination in health examination held from fiscal 2009 to fiscal 2013

Control group: Recipients aged >=30 with no history of RE on records of health examination held from fiscal 2004 to fiscal 2013
Key exclusion criteria 1) Patients or Recipients who do not take health examination held at least 3 fiscal years among the 5 fiscal years just before RE onset

2) Patients or Recipients who have undergone gastrointestinal resection or vagotomy
Target sample size 1800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Joh
Organization Nagoya City University
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawazumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, Japan
TEL 052-853-8211
Email tjoh@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Kubota
Organization Nagoya City University
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawazumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, Japan
TEL 052-853-8211
Homepage URL
Email ekubota@med.nagoya-cu.ac.jp

Sponsor
Institute Society for GERD
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization AstraZeneca K.K.
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
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 24 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
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 Main results already published
Date of protocol fixation
2013 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 18 Day
Last follow-up date
2015 Year 01 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 07 Month 31 Day

Other
Other related information The primary objective is to determine factors for predicting future RE onset using health examination data and changes in these data over time determined by reviewing the examination data over the past 5 years of patients newly diagnosed with RE in a health examination (hereafter called "new RE patients") and comparing the data to the examination data over the past 5 years of a control population matched with the new RE patients in terms of sex, age, timing of testing, and institution.

Management information
Registered date
2014 Year 07 Month 24 Day
Last modified on
2017 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017033


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