UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046547 |
|---|---|
| Receipt number | 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 13:53:30 |
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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
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
k.adachi@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi-medical university of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053107
