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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046547
Receipt No. R000053107
Scientific Title The retrospective study for Vonoprazan, clarithromycin, and metronidazole regimen for Helicobacter pylori eradication therapy for patients with penicillin allergy in view of clarithromycin-resistance
Date of disclosure of the study information 2022/01/05
Last modified on 2022/01/05

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Basic information
Public title The retrospective study for Vonoprazan, clarithromycin, and metronidazole regimen for Helicobacter pylori eradication therapy for patients with penicillin allergy in view of clarithromycin-resistance
Acronym The retrospective study for Vonoprazan, clarithromycin, and metronidazole regimen for Helicobacter pylori eradication therapy for patients with penicillin allergy in view of clarithromycin-resistance
Scientific Title The retrospective study for Vonoprazan, clarithromycin, and metronidazole regimen for Helicobacter pylori eradication therapy for patients with penicillin allergy in view of clarithromycin-resistance
Scientific Title:Acronym The retrospective study for Vonoprazan, clarithromycin, and metronidazole regimen for Helicobacter pylori eradication therapy for patients with penicillin allergy in view of clarithromycin-resistance
Region
Japan

Condition
Condition Helicobacter pylori for patients with penicillin allergy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of treatment with bonoprazan, clarithromycin, and metronidazole for penicillin-allergic, clarithromycin-resistant Helicobacter pylori infection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy of different treatment methods (proton pump inhibitor/bonoprazole + clarithromycin + metronidazole, bonoprazole + metronidazole + sitafloxatin) for penicillin-allergic Helicobacter spp. positive patients at our hospital(To be determined by urea breath test at least 2 months after completion of administration)
Key secondary outcomes Safety of Treatment
Comparison of the difference in efficacy of the following eradication treatments in patients treated with bonoprazan, clarithromycin, and metronidazole with and without clarithromycin resistance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PPI (esomeprazole 20mg 2T, lansoprazole 30mg 2T, or rabeprazole na 10mg 2Tb) + clarithromycin 200mg 2T + MNZ 250mg 2T for 7 days
Interventions/Control_2 Bonoprazole 20 mg 2 T+ clarithromycin 200mg 2T + MNZ 250mg 2T for 7 days
Interventions/Control_3 Bonoprazole 20 mg 2 T+sitafloxacin50mg 2T + MNZ 250mg 2T for 7 days
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Penicillin-allergic patients who received eradication treatment for Helicobacter pylori at our hospital
Key exclusion criteria In the case that the current infection of Helicobacter pylori cannot be confirmed
If you do not wish to pay for your own treatment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Sasaki
Organization Aichi-medical university of medicine
Division name gastroenterology
Zip code 4801103
Address 1-1Karimata Yazako ngakute city Aichi
TEL 0561623311
Email sasaki.makoto.900@mail.aichi-med-u.ac.jp

Public contact
Name of contact person
1st name kazunori
Middle name
Last name Adachi
Organization Aichi-medical university of medicine
Division name gastroenterology
Zip code 4801103
Address 1-1Karimata Yazako ngakute city Aichi
TEL 0561623311
Homepage URL
Email k.adachi@aichi-med-u.ac.jp

Sponsor
Institute Aichi-medical university of medicine
Institute
Department

Funding Source
Organization Aichi-medical university of medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Aichi-medical university of medicine
Address 1-1Karimata Yazako ngakute city Aichi
Tel 0561623311
Email k.adachi@aichi-med-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2021 Year 06 Month 01 Day
Date of IRB
2015 Year 02 Month 24 Day
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 05 Day
Last modified on
2022 Year 01 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053107

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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