Unique ID issued by UMIN | UMIN000021604 |
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Receipt number | R000024888 |
Scientific Title | Prospective multicenter cohort study to evaluate the efficacy and safety of Helicobacter pylori eradication therapy |
Date of disclosure of the study information | 2016/03/25 |
Last modified on | 2021/10/01 14:41:21 |
Prospective multicenter cohort study to evaluate the efficacy and safety of Helicobacter pylori eradication therapy
Prospective multicenter cohort study of H. pylori eradication
Prospective multicenter cohort study to evaluate the efficacy and safety of Helicobacter pylori eradication therapy
Prospective multicenter cohort study of H. pylori eradication
Japan |
Helicobacter pylori infection
Gastroenterology |
Others
NO
To compare the efficacy and safety of H. pylori eradication therapy between P-CAB (vonoprazan) and PPI based, as a prospective multicenter cohort study and retrospective study.
And to evaluate the factors affecting post-eradication gastric carcinogenesis and reinfection of H. pylori by a long-term follow-up of the cohort.
Safety,Efficacy
Confirmatory
Pragmatic
Comparison of eradication rate by
1) Regimens (P-CAB/AMPC/CAM 1week, PPI/AMPC/CAM 1week, P-CAB/AMPC/MNZ 1week, P-CAB/AMPC/MNZ 1week, etc.)
2) Eradication number of times (first line, second line, etc.)
3) prospective, retrospective
4) Antibiotic-resistance of H. pylori (CAM resistance, MNZ resistance, etc.)
5) Another factors that affect the eradication (smoking etc.).
Success of eradication was assessed by urea breath test or H. pylori stool antigen test more than 4 weeks after treatment
1)Safety evaluated by side effects questionnaire filled by patients during therapy
2)Rate of post-eradication gastric carcinogenesis, reinfection of H. pylori, and factors affecting them
Interventional
Factorial
Non-randomized
Open -no one is blinded
Active
4
Treatment
Medicine |
Vonoprazan 20mg bid
Amoxicillin 750mg bid
Clarithromycin 200mg or 400mg bid
1week
Lansoprazole 30mg, Rabeprazole 10mg, Omeprazole 20mg,or Esomeprazole 20mg bid
Amoxicillin 750mg bid
Clarithromycin 200mg or 400mg bid
1week
Vonoprazan 20mg bid
Amoxicillin 750mg bid
Metronidazole 250mg bid
1week
Lansoprazole 30mg, Rabeprazole 10mg, Omeprazole 20mg,or Esomeprazole 20mg bid
Amoxicillin 750mg bid
Metronidazole 250mg bid
1week
20 | years-old | <= |
Not applicable |
Male and Female
<Prospective study>
A patient with H.pylori infection.
A patient who give a written informed consent.
<Retrospective study>
A patient who performed H. pylori eradication therapy in participation institutes of this study after November 2009.
A patient who give informed consent as opt-out in each participation institutes of this study.
<Prospective study>
A patient participating in UMIN000016335(PCAB-based H.pylori eradication study for patients with penicillin allergy), UMIN000016336(PCAB-based H.pylori third line eradication study), UMIN000016337(PCAB-based H.pylori first line eradication study), or UMIN000019628(Efficacy of UBT after PCAB-based H.pylori eradication)
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.
<Retrospective study>
A patient participating in UMIN000016335(PCAB-based H.pylori eradication study for patients with penicillin allergy), UMIN000016336(PCAB-based H.pylori third line eradication study), UMIN000016337(PCAB-based H.pylori first line eradication study), or UMIN000019628(Efficacy of UBT after PCAB-based H.pylori eradication)
2000
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 Gastro Intestinal Study Group(YGISG):
Yokohama City University Medical Center, Yokohama Minami Kyousai Hospital, Saiseikai Yokohamashi Nanbu Hospital, Fujisawa City Hospital, Kanagawa Cancer Center, Yokohama Hodogaya Central Hospital, Yokohama Ekisaikai Hospital, Kanagawa Prefectual Ashigarakami Hospital, Yokosuka City Hospital, Japanese Red Cross Hadano Hospital, Fujisawa Shounandai Hospital
Yokohama City University Ethics Committee
Fukuura3-9, Kanazawa-ku, 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)
2016 | Year | 03 | Month | 25 | Day |
https://pubmed.ncbi.nlm.nih.gov/28566587/
Partially published
https://pubmed.ncbi.nlm.nih.gov/28566587/
1593
The first-line eradication rates (ER) in the ITT and PP analyses were 84.9% and 86.4%, respectively, for VAC and 78.8% and 79.4%, respectively, for PAC. The ER of VAC was higher than that of PAC in the ITT (p=0.0061) and PP analyses (p=0.0013). In the second-line ITT and PP analyses VAM achieved ERs of 80.5% and 82.4%, respectively, while PAM achieved ERs of 81.5% and 82.1%, respectively. No significant differences were observed in the ITT (p=0.89) or PP (p=1.0) analyses.
2021 | Year | 10 | Month | 01 | Day |
Baseline characteristics for first line VAC were 64.3 years (age) and male 54.4%, and for first line PAC were 64.5 years and male 56.9%.
Baseline characteristics for second line VAM were 67.5 years and male 57.8%, and for the second line PAM were 63.9 year and male 45.5%.
1770 screened for eligibility, and the 1231 for first line eradication and the 362 for second line eradication were recruited.
PAC was associated with higher AEQ scores than VAC for diarrhea, nausea, headache, and general malaise.
The first-line eradication rates (ER) in the ITT and PP analyses were 84.9% and 86.4%, respectively, for VAC and 78.8% and 79.4%, respectively, for PAC. The ER of VAC was higher than that of PAC in the ITT (p=0.0061) and PP analyses (p=0.0013). In the second-line ITT and PP analyses VAM achieved ERs of 80.5% and 82.4%, respectively, while PAM achieved ERs of 81.5% and 82.1%, respectively. No significant differences were observed in the ITT (p=0.89) or PP (p=1.0) analyses.
Completed
2015 | Year | 05 | Month | 18 | Day |
2015 | Year | 05 | Month | 18 | Day |
2015 | Year | 05 | Month | 26 | Day |
2020 | Year | 06 | Month | 24 | Day |
2016 | Year | 03 | Month | 24 | Day |
2021 | Year | 10 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024888
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