Unique ID issued by UMIN | UMIN000016336 |
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Receipt number | R000018956 |
Scientific Title | Randomized Controlled Trial for H.pylori third line eradication therapy: PPI vs PCAB |
Date of disclosure of the study information | 2015/02/01 |
Last modified on | 2020/01/30 18:00:23 |
Randomized Controlled Trial for H.pylori third line eradication therapy: PPI vs PCAB
PCAB-based H.pylori third line eradication study (CAP-3 study)
Randomized Controlled Trial for H.pylori third line eradication therapy: PPI vs PCAB
PCAB-based H.pylori third line eradication study (CAP-3 study)
Japan |
Helicobacter pylori infection
Gastroenterology |
Others
NO
To evaluate the efficacy and safety of PCAB for third line H.pylori eradication.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Comparison of third line H.pylori eradication rate of the two regimens, sitafloxacin(STFX) +amoxicillin(AMPC)+ P-CAB vs sitafloxacin(STFX) +amoxicillin(AMPC)+ PPI
Comparison of Safety of the two regimens, sitafloxacin(STFX) +amoxicillin(AMPC)+ P-CAB vs sitafloxacin(STFX) +amoxicillin(AMPC)+ PPI
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
sitafloxacin(STFX) +amoxicillin(AMPC)+ P-CAB
sitafloxacin(STFX) +amoxicillin(AMPC)+ PPI
20 | years-old | <= |
Not applicable |
Male and Female
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.
Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction. Patients who are disqualified for the study by physicians.
126
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 Ethics Committee
Fukuura 3-9, Kanazawa, Yokohama City, Kanagawa
045-370-7627
rinri@yokohama-cu.ac.jp
NO
横浜市立大学付属病院(神奈川県)Yokohama City University Hospital
(kanagawa)
2015 | Year | 02 | Month | 01 | Day |
Partially published
https://www.ncbi.nlm.nih.gov/pubmed/30151994
87
Completed
2015 | Year | 01 | Month | 15 | Day |
2015 | Year | 02 | Month | 01 | Day |
2015 | Year | 02 | Month | 01 | Day |
2019 | Year | 03 | Month | 28 | Day |
2019 | Year | 03 | Month | 29 | Day |
2019 | Year | 03 | Month | 29 | Day |
2019 | Year | 03 | Month | 31 | Day |
2015 | Year | 01 | Month | 26 | Day |
2020 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018956
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