UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017061 |
|---|---|
| Receipt number | R000019784 |
| Scientific Title | A study to evaluate the efficacy of third regimen with vonoprazan for eradication of Helicobacter pylori resistant against first and second regimen. |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2022/02/22 22:08:46 |
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Basic information
Public title
A study to evaluate the efficacy of third regimen with vonoprazan for eradication of Helicobacter pylori resistant against first and second regimen.
Acronym
Third regimen with vonoprazan for eradication of Helicobacter pylori.
Scientific Title
A study to evaluate the efficacy of third regimen with vonoprazan for eradication of Helicobacter pylori resistant against first and second regimen.
Scientific Title:Acronym
Third regimen with vonoprazan for eradication of Helicobacter pylori.
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Medicine in general | Gastroenterology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of third regimen with vonoprazan for eradication of Helicobacter pylori resistant against first and second regimen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication rate of Helicobacter pylori
Key secondary outcomes
Rate of adverse events
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
Patient receive the regimen shown below for seven days.
Vonoprazan 20mg twice a day
metronidazole 250mg twice a day
amoxicillin 750mg twice a day
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
A patient who failed first and second regimen for eradication of Helicobacter pylori.
Key exclusion criteria
A patient who took antibacterial drug or antacid drug within one month.
A patient who has allergic hypersensitivity against the drugs used in this study.
A patient who are judged to be inappropriate for this study by doctors conducting the study.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinnosuke Tokoro |
Organization
Shonan Kamakura General Hospital
Division name
Gastroenterology medicine center
Zip code
Address
1370-1 Okamoto,Kamakura City,Kanagawa Prefecture
TEL
0467-46-1717
tocotocotack@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinnosuke Tokoro |
Organization
Shonan Kamakura General Hospital
Division name
Gastroenterology medicine center
Zip code
Address
1370-1 Okamoto,Kamakura City,Kanagawa Prefecture
TEL
0467-46-1717
Homepage URL
tocotocotack@hotmail.co.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura General Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 04 | Month | 22 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2015 | Year | 04 | Month | 07 | Day |
Last modified on
| 2022 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019784
