UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024290 |
|---|---|
| Receipt number | R000027979 |
| Scientific Title | The study of H.pylori third line eradication therapy using Vonoprazan |
| Date of disclosure of the study information | 2016/10/05 |
| Last modified on | 2019/06/04 15:29:29 |
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Basic information
Public title
The study of H.pylori third line eradication therapy using Vonoprazan
Acronym
The study of H.pylori third line eradication therapy using Vonoprazan
Scientific Title
The study of H.pylori third line eradication therapy using Vonoprazan
Scientific Title:Acronym
The study of H.pylori third line eradication therapy using Vonoprazan
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Related study with eradication results,antimicrobial drug resisutance and H.pylori gene in H.pylori third line eradication therapy and to evaluate safety
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Related study with eradication results,antimicrobial drug resisutance and H.pylori gene in H.pylori third line eradication therapy
Key secondary outcomes
To evaluate safety of H.pylori third line eradication therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
vonopurazan+metoronidazole(MNZ)+sitafloxacin(STFX)
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
First line eradication(PPI+AMPC+CAM)and second line eradication(PPI+AMPC+MNZ)failure patients with H.pylori infection who want to take eradication treatment. Patients who give a written informed consent.
Key exclusion criteria
Pregnancy or lactation. Past history of allergy for the drugs used in this therapy . Sever liver dysfunction, sever renal dysfunction, sever heart dysfunction. Patients who are disqualified for the sutdy by physicians.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Inoue |
| Middle name | |
| Last name | Syuji |
Organization
National Hospital Organization National Kochi Hospital
Division name
gstroenterology
Zip code
780-8507
Address
1-2-25, Asakuranishimachi, Kochi, 780-8077, Japan
TEL
088-844-3111
inoue.shuji.cs@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Inoue/Eguchi |
| Middle name | |
| Last name | Syuji / Sizuka |
Organization
National Hospital Organization National Kochi Hospital
Division name
gstroenterology
Zip code
780-8507
Address
1-2-25, Asakuranishimachi, Kochi, 780-8077, Japan
TEL
088-844-3111
Homepage URL
inoue.shuji.cs@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization National Kochi Hospital
gstroenterology
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization National Kochi Hospital
gstroenterology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kochi University medical school
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization National Kochi Hospital
Address
1-2-25, Asakuranishimachi, Kochi, 780-8077, Japan
Tel
088-844-3111
inoue.shuji.cs@mail.hosp.go.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
独立行政法人国立病院機構高知病院
高知大学医学部病態情報診断学教室
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 05 | 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 | 09 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 04 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027979
