Unique ID issued by UMIN | UMIN000022920 |
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Receipt number | R000026412 |
Scientific Title | Prospective multicenter non-randomized parallel-group comparative study to evaluate the efficacy of P-CAB/AMPC/MNZ 7 day triple therapy as first line eradication of CAM-resistant Helicobacter pylori: superiority study compared to P-CAB/AMPC/CAM, non-inferiority study compared to PPI/AMPC/MNZ, superiority study compared to PPI/AMPC/CAM |
Date of disclosure of the study information | 2016/06/28 |
Last modified on | 2020/02/06 13:45:59 |
Prospective multicenter non-randomized parallel-group comparative study to evaluate the efficacy of P-CAB/AMPC/MNZ 7 day triple therapy as first line eradication of CAM-resistant Helicobacter pylori: superiority study compared to P-CAB/AMPC/CAM, non-inferiority study compared to PPI/AMPC/MNZ, superiority study compared to PPI/AMPC/CAM
P-CAB/AMPC/MNZ 7 day triple therapy as first line eradication of CAM-resistant Helicobacter pylori
Prospective multicenter non-randomized parallel-group comparative study to evaluate the efficacy of P-CAB/AMPC/MNZ 7 day triple therapy as first line eradication of CAM-resistant Helicobacter pylori: superiority study compared to P-CAB/AMPC/CAM, non-inferiority study compared to PPI/AMPC/MNZ, superiority study compared to PPI/AMPC/CAM
P-CAB/AMPC/MNZ 7 day triple therapy as first line eradication of CAM-resistant Helicobacter pylori
Japan |
Helicobacter pylori infection
Gastroenterology |
Others
NO
To varity the efficacy and safety of P-CAB/AMPC/MNZ 7 day triple therapy as first line eradication of CAM-resistant Helicobacter pylori: superiority study compared to P-CAB/AMPC/CAM, non-inferiority study compared to PPI/AMPC/MNZ, superiority study compared to PPI/AMPC/CAM as prospective multicenter non-randomized parallel-group comparative study.
Safety,Efficacy
Confirmatory
Pragmatic
Comparison of eradication rate between P-CAB/AMPC/MNZ and P-CAB/AMPC/CAM or PPI/AMPC/MNZ or PPI/AMPC/CAM.
Success of eradication was assessed by urea breath test or H. pylori stool antigen test more than 6 weeks after treatment.
Safety evaluated by side effects questionnaire filled by patients during the therapy.
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
4
Treatment
Medicine |
Vonoprazan 20mg bid
Amoxicillin 750mg bid
Metronidazole 250mg bid
1 week
Vonoprazan 20mg bid
Amoxicillin 750mg bid
Clarithromycin 200mg or 400mg bid
1 week
Lansoprazole 30mg, Rabeprazole 10mg, Omeprazole 20mg, or Esomeprazole 20mg bid
Amoxicillin 750mg bid
Metronidazole 250mg bid
1 week
Lansoprazole 30mg, Rabeprazole 10mg, Omeprazole 20mg, or Esomeprazole 20mg bid
Amoxicillin 750mg bid
Clarithromycin 200mg or 400mg bid
1 week
20 | years-old | <= |
Not applicable |
Male and Female
A patient with CAM-resistant H. pylori infection
A patient who give a written informed consent
Past history of taking eradication therapy. Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. 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.
189
1st name | Shin |
Middle name | |
Last name | Maeda |
Yokohama City University Hospital
Gastroenterology
236-0004
Fukuura3-9, Kanagawa, 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
Yokosuka City Hospital, Yokohama Hodogaya Central Hospital, Yokohama Minami Kyousai Hospital
Yokohama City University Ethics Committee
Fukuura3-9, Kanazawa-ku, Yokohama city, Kanagawa
045-370-7627
rinri@yokohama-cu.ac.jp
NO
2016 | Year | 06 | Month | 28 | Day |
Unpublished
Completed
2016 | Year | 05 | Month | 24 | Day |
2016 | Year | 05 | Month | 24 | Day |
2016 | Year | 06 | Month | 28 | Day |
2018 | Year | 12 | Month | 01 | Day |
2016 | Year | 06 | Month | 27 | Day |
2020 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026412
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