UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032351 |
|---|---|
| Receipt number | R000036883 |
| Scientific Title | A retrospective study in clinical course of Heicobacter pylori eradication therapy |
| Date of disclosure of the study information | 2018/04/25 |
| Last modified on | 2018/10/22 11:30:56 |
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Basic information
Public title
A retrospective study in clinical course of Heicobacter pylori eradication therapy
Acronym
H. pylori eradication therapy
Scientific Title
A retrospective study in clinical course of Heicobacter pylori eradication therapy
Scientific Title:Acronym
H. pylori eradication therapy
Region
| Japan |
Condition
Condition
H.pylori infected patients
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims are to compare success rates in H. pylori eradication therapies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcome is non-inferiority of vonoprazan-based therapy for other regimens including PPI-based therapy.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who received eradication therapy(vonoprazan, PPI)
Key exclusion criteria
patient who refused the therapy
Target sample size
427
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Tanabe |
Organization
International University of Health and Welfare Hospital
Division name
Department of Gastroenterology
Zip code
Address
537-3 Iguchi Nasushiobara, Tochigi
TEL
+81-287393060
tant@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Tanabe |
Organization
International University of Health and Welfare Hospital
Division name
Department of Gastroenterology
Zip code
Address
537-3 Iguchi Nasushiobara, Tochigi
TEL
+81-287393060
Homepage URL
tant@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1186/s12941-018-0281-x
Number of participants that the trial has enrolled
Results
Vonoprazan-based triple therapy was effective as susceptibility-guided triple therapy for H. pylori eradication.
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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 25 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2018 | Year | 04 | Month | 23 | Day |
Last modified on
| 2018 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036883
