Unique ID issued by UMIN | UMIN000032109 |
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Receipt number | R000036631 |
Scientific Title | Sequential therapy with vonoprazan, amoxicillin 7 days and vonoprazan, metronidazole, and sitafloxacin 7 days versus triple therapy with vonoprazan, amoxicillin, and metronidazole 7days for early age Helicobacter pylori infection: a multicentre, open-label, randomised trial |
Date of disclosure of the study information | 2018/04/06 |
Last modified on | 2020/02/06 13:30:34 |
Sequential therapy with vonoprazan, amoxicillin 7 days and vonoprazan, metronidazole, and sitafloxacin 7 days versus triple therapy with vonoprazan, amoxicillin, and metronidazole 7days for early age Helicobacter pylori infection: a multicentre, open-label, randomised trial
RCT comparing VA-VMS sequential and VAM HP eradication for Early age patients
Sequential therapy with vonoprazan, amoxicillin 7 days and vonoprazan, metronidazole, and sitafloxacin 7 days versus triple therapy with vonoprazan, amoxicillin, and metronidazole 7days for early age Helicobacter pylori infection: a multicentre, open-label, randomised trial
RCT comparing VA-VMS sequential and VAM HP eradication for Early age patients
Japan |
Helicobacter pylori infection
Gastroenterology |
Others
NO
To compare the efficacy and safety between sequential therapy with vonoprazan-amoxicillin and vonoprazan-metronidazole-sitafloxacin and triple therapy with vonoprazan-amoxicillin-metronidazole as the first-line treatment for Helicobacter pylori positive patients less than 40 year-old.
Safety,Efficacy
Eradication rate assessed by stool antigen test of Helicobacter pylori more than 8 weeks after treatment
Adverse event evaluated by side effect questionnaire filled by patients
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
A 14-day sequential therapy conaining vonoprazan and amoxicillin for 7 days followed by vonoprazan, metronidazole and sitafloxacin for 7 days
: Vonoprazan 20mg bid
Amoxicillin 750mg bid
7 days
followed by
Vonoprazan 20mg bid
Metronidazole 250mg bid
Sitafloxacin 100mg bid
7 days
(Total 14 days)
A 7-day triple therapy with vonoprazan, amoxicillin, and metronidazole
:Vonoprazan 20mg bid
Amoxicillin 750mg bid
Metronidazole 250mg bid
7 days
20 | years-old | <= |
40 | years-old | >= |
Male and Female
(1) A patient with Helicobacter pylori infection.
(2) A patient who can perform stool antigen test of Helicobacter pylori after 8 weeks from treatment completion.
(3)A patient who give a written informed consent.
(1) A patient with history of Helicobacter pylori eradication.
(2) Pregnancy.
(3) Lactation.
(4) Patients allergic to penicillin.
(5) Past history of allergy for the drugs used in this study.
(6) A patient with brain and spinal cord disease.
(7) A patient with infectious mononucleosis.
(8) Severe liver dysfunction, serere renal dysfunction, severe heart dysfunction.
(9) Patient who is disualified for the study by physicians.
190
1st name | Shin |
Middle name | |
Last name | Maeda |
Yokohama City University Hospital
Gastroenterology
236-0004
Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
045-787-2326
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
045-787-2326
ssue@yokohama-cu.ac.jp
Yokohama City University Hospital
Yokohama City University (Basic research expenditures)
Other
Yokohama City University Certified Institutional Review Board
Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa
045-370-7627
ycu_crb@yokohama-cu.ac.jp
NO
2018 | Year | 04 | Month | 06 | Day |
Unpublished
Open public recruiting
2018 | Year | 03 | Month | 22 | Day |
2018 | Year | 09 | Month | 01 | Day |
2018 | Year | 04 | Month | 04 | Day |
2020 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036631
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