UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021993 |
|---|---|
| Receipt number | 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 16:59:53 |
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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)
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
ajisai@mebix.co.jp
Sponsor or person
Institute
AstraZeneca K.K. Medical
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
