UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025773 |
|---|---|
| Receipt number | R000029644 |
| Scientific Title | A randomized controlled trial comparing Vonoprazan, Amoxicillin and Metronidazole triple therapy and Vonoprazan, Amoxicillin and Clarithromycin triple therapy as a first-line eradication of Helicobacter pylori |
| Date of disclosure of the study information | 2017/01/22 |
| Last modified on | 2020/02/06 13:24:58 |
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Basic information
Public title
A randomized controlled trial comparing Vonoprazan, Amoxicillin and Metronidazole triple therapy and Vonoprazan, Amoxicillin and Clarithromycin triple therapy as a first-line eradication of Helicobacter pylori
Acronym
RCT comparing VAM and VAC HP eradication as first-line
Scientific Title
A randomized controlled trial comparing Vonoprazan, Amoxicillin and Metronidazole triple therapy and Vonoprazan, Amoxicillin and Clarithromycin triple therapy as a first-line eradication of Helicobacter pylori
Scientific Title:Acronym
RCT comparing VAM and VAC HP eradication as first-line
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety between Vonoprazan/Amoxicillin/Metronidazole and Vonoprazan/Amoxicillin/Clarithromycin 7 day triple therapy for first-line Helicobacter pylori eradication therapy in cases without susceptibility testing.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication rate assessed by urea breath test more than 8 weeks after treatment
Key secondary outcomes
Safety evaluated by side effect questionnaire filled by patients.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vonoprazan 20mg bid
Amoxicillin 750mg bid
Metronidazole 250mg bid
7 days
Interventions/Control_2
Vonoprazan 20mg bid
Amoxicillin 750mg bid
Clarithromycin 200mg bid
7 days
Interventions/Control_3
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient with Helicobacter pylori infection without history of Helicobacter pylori eradication.
A patient without susceptibility testing result of Helicobacter pyori.
A patient who can perform urea breath test after 8 weeks from treatment completion.
A patient who give a written informed consent.
Key exclusion criteria
Pregnancy or lactation. Past history of allergy for the drugs used in this study.
A patient with brain and spinal cord disease. A patient with infectious mononucleosis. Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. Patient who is disqualified for the study by physicians.
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Maeda |
Organization
Yokohama City University Hospital
Division name
Gastroenterology
Zip code
236-0004
Address
Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL
045-261-5656
smaeda@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Sue |
Organization
Yokohama City University Hospital
Division name
Gastroenterology
Zip code
236-0004
Address
Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL
045-261-5656
Homepage URL
ssue@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University (Basic research expenditures)
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University (Basic research expenditures)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethics Committee
Address
Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa
Tel
045-370-7627
rinri@yokohama-cu.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
| 2017 | Year | 01 | Month | 22 | 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
124
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
| 2016 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 20 | Day |
Last modified on
| 2020 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029644
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
