UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021418 |
|---|---|
| Receipt number | R000024674 |
| Scientific Title | The effective of the triple therapy for clarithromycin-resistant Helicobacter pylori using Vonoprazan,AMPC,MNZ. |
| Date of disclosure of the study information | 2016/03/10 |
| Last modified on | 2017/02/03 16:50:25 |
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Basic information
Public title
The effective of the triple therapy for clarithromycin-resistant Helicobacter pylori using Vonoprazan,AMPC,MNZ.
Acronym
Eradication therapy for CAM-resistant Helicobacter pylori.
Scientific Title
The effective of the triple therapy for clarithromycin-resistant Helicobacter pylori using Vonoprazan,AMPC,MNZ.
Scientific Title:Acronym
Eradication therapy for CAM-resistant Helicobacter pylori.
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Varify the effecacy of first line triple therapy for the clarithromycin-resistant Helicobacter pylori using vonoprazan, amoxicillin and metronidazole.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eradication rate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Helicobacter pylori infected patient
Key exclusion criteria
Penicillin allergy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisatsugu Noda |
Organization
Aichi medical university
Division name
gastroenterology
Zip code
Address
1-1 yazakokarimata Nagakute city Aichi
TEL
0561-62-3311
bisaipan@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisatsugu Noda |
Organization
Aichi medical university
Division name
gastroenterology
Zip code
Address
1-1 yazakokarimata Nagakute city Aichi
TEL
0561-62-3311
Homepage URL
bisaipan@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi medical university
Institute
Department
Personal name
Funding Source
Organization
Aichi 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
| 2016 | Year | 03 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
All the members who were equal to criteria for selection in the patients who consulted our institution in March, 2019 from April, 2016
Management information
Registered date
| 2016 | Year | 03 | Month | 10 | Day |
Last modified on
| 2017 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024674
