Unique ID issued by UMIN | UMIN000025765 |
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Receipt number | R000029638 |
Scientific Title | A pilot study of Susceptibility testing based Fourth-line Helicobacter pylori eradication therapy |
Date of disclosure of the study information | 2017/01/22 |
Last modified on | 2022/01/24 10:38:37 |
A pilot study of Susceptibility testing based Fourth-line Helicobacter pylori eradication therapy
Susceptibility based Fourth-line eradication
A pilot study of Susceptibility testing based Fourth-line Helicobacter pylori eradication therapy
Susceptibility based Fourth-line eradication
Japan |
Helicobacter pylori infection
Gastroenterology |
Others
NO
To varify the efficacy and safety of susceptibility testing based fourth-line two-weeks Helicobacter pylori eradication therapy with vonoprazan, amoxicillin, clarithromycin and metronidazole.
Safety,Efficacy
Eradication rate assessed by urea breath test more than 8 weeks after treatment
Safety evaluated by side effects questionnaire filled by patients
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
Vonoprazan 20mg bid
Amoxicillin 500mg qid
Clarithromycin 400mg bid
Metronidazole 250mg bid
2 weeks
This regimen is used with modification based on susceptibility testing.
20 | years-old | <= |
Not applicable |
Male and Female
A patient with Helicobacter pylori infection failed for first, second (one week triple therapy with acid suppressant and amoxicillin and clarithromycin or metronidazole) and sitafloxacin based third line eradication .
A patient who was diagnosed for Helicobacter pylori infection by urea breath test or Helicobacter pylori stool antigen test.
A patient who can perform urea breath test after 8 weeks from treatment completion.
A patient who give a written informed consent.
A patient who don't agree for endoscopy and susceptible testing as own expense medical care before eradication therapy.
Past history of allergy or side effect requiring treatment for the drugs used in this study.
Pregnancy or lactation. A patient with brain and spinal cord disease. A patient with infectious mononucleosis. Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. Patients who are disqualified for the study by physicians.
30
1st name | Shin |
Middle name | |
Last name | Maeda |
Yokohama City University Hospital
Gastroenterology
236-0004
Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
045-261-5656
smaeda@med.yokohama-cu.ac.jp
1st name | Soichiro |
Middle name | |
Last name | Sue |
Yokohama City University Hospital
Gastroenterology
236-0004
Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
045-261-5656
ssue@yokohama-cu.ac.jp
Yokohama City University Hospital
Yokohama City University (Basic research expenditures)
Other
Japan
Yokohama City University Certified Institutional Review Board
Fukuura3-9, Kanazawa-ku, Yokohama city, Kanagawa
045-370-7627
ycu_crb@yokohama-cu.ac.jp
NO
2017 | Year | 01 | Month | 22 | Day |
Unpublished
Completed
2016 | Year | 12 | Month | 16 | Day |
2016 | Year | 12 | Month | 16 | Day |
2017 | Year | 01 | Month | 22 | Day |
2021 | Year | 04 | Month | 12 | Day |
2017 | Year | 01 | Month | 20 | Day |
2022 | Year | 01 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029638
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