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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021993
Receipt No. R000025107
Scientific Title Assessment of RE symptoms in Japan and evaluation of treatment satisfaction
Date of disclosure of the study information 2016/08/18
Last modified on 2016/08/18

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Basic information
Public title Assessment of RE symptoms in Japan and evaluation of treatment satisfaction
Acronym AJISAI
(Assessment of RE symptoms in Japan and evaluatIon of treatment SAtIsfaction)
Scientific Title Assessment of RE symptoms in Japan and evaluation of treatment satisfaction
Scientific Title:Acronym AJISAI
(Assessment of RE symptoms in Japan and evaluatIon of treatment SAtIsfaction)
Region
Japan

Condition
Condition Reflux esophagitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the factors which have an effect on the treatment satisfaction in patients with Japanese reflux esophagitis (RE), and to assess the degree of those factors on the treatment satisfaction
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The appropriate multivariate regression model is developed by using the treatment satisfaction questionnaire (TSQ) score as the response variable, by using the baseline characteristics and the degree (severity or frequency) of RE related subjective symptoms as the explanatory variables. Furthermore, the coefficient of determination and the standardized regression coefficient of that model are calculated.
Key secondary outcomes The appropriate multivariate regression model is developed by using the satisfaction score which is TSQ's sub-category as the response variable, by using the other sub-categories, the baseline characteristics and the degree of RE related subjective symptoms as the explanatory variables. Furthermore, the coefficient of determination and the standardized regression coefficient of that model are calculated.

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.Patients who give informed consent through the internet.

2.Patients who are 20 years of age and older at the time of receiving IC.

3.Patients who are diagnosed as a RE by doctors

4. Patients who are administered one or more drugs prescribed by doctors among the followings used to treat RE for at least more than four weeks to make heartburn and acid reflux disappear or to achieve lasting remission.
Key exclusion criteria Subjects suspected of poor capability follow instructions of the survey.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name AstraZeneca K.K. Evidence & Observational research Medical
Organization AstraZeneca K.K.
Division name Evidence & Observational research Medical
Zip code
Address Grand Front Osaka Tower B, 3-1, Ofuka-cho, Kita-ku, Osaka 530-0011, Japan
TEL 06-4802-3600(+81-6-4802-3600)
Email ajisai@mebix.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Osawa
Organization Mebix, Inc.
Division name Research Promotion
Zip code
Address TORANOMON TOWERS OFFICE 14F, 4-1-28 Toranomon, Minato-ku, Tokyo, 105-0001, Japan
TEL 03-6860-6980(+81-3-6860-6980)
Homepage URL
Email ajisai@mebix.co.jp

Sponsor
Institute AstraZeneca K.K. Medical
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 なし/none

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 18 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
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
2016 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2016 Year 04 Month 20 Day
Last modified on
2016 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025107

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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