UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014727 |
|---|---|
| Receipt number | R000017121 |
| Scientific Title | Eradication therapy of the junior high student in H. pylori |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2020/08/20 15:24:01 |
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Basic information
Public title
Eradication therapy of the junior high student in H. pylori
Acronym
H. pylori eradication of the junior high student
Scientific Title
Eradication therapy of the junior high student in H. pylori
Scientific Title:Acronym
H. pylori eradication of the junior high student
Region
| Japan |
Condition
Condition
H. pylori infection
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
H. pylori eradication
Basic objectives2
Others
Basic objectives -Others
prevention of H. pylori associated diseases
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
H. pylori eradication
Key secondary outcomes
Evaluation of H. pylori associated diseases
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eradication therapy
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
| 12 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Helicobacter pyroli infection
Key exclusion criteria
Past history of Helicobacter pyroli eradication
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Ashida |
Organization
Osaka Medical College
Division name
Dep. of Pediatrics
Zip code
569-8686
Address
2-7, Daigakumachi,Takatsuki, Osaka, Japan
TEL
072-683-1221
ped006@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Emiri |
| Middle name | |
| Last name | Kaji |
Organization
Osaka Medical College
Division name
Dep. of Pediatrics
Zip code
569-8686
Address
2-7, Daigakumachi,Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
ped097@osaka-med.ac.jp
Sponsor or person
Institute
Takatsuki city health center
Institute
Department
Personal name
Funding Source
Organization
Takatsuki city
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Dep. of Pediatrics. Osaka Medical College
Address
2-7,Daigakumachi, Takatsuki city, Osaka, Japan
Tel
072-683-1221
ped097@osaka-med.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
大阪医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 31 | Day |
Last modified on
| 2020 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017121
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
