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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022846
Receipt No. R000026328
Scientific Title Study of Vonoprazan-based triple theary for eradication of helicobacter pylori
Date of disclosure of the study information 2016/07/01
Last modified on 2018/10/12

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Basic information
Public title Study of Vonoprazan-based triple theary for eradication of helicobacter pylori
Acronym Eradication with Vonoprazan
Scientific Title Study of Vonoprazan-based triple theary for eradication of helicobacter pylori
Scientific Title:Acronym Eradication with Vonoprazan
Region
Japan

Condition
Condition gastritis with helicobacter pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate Vonoprazan-based triple thearpy for helicobacter pylori compare to PPI-based triple thearpy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Success rate of the eradication therapy after one month later by urea breath test
Key secondary outcomes Mortality and morbidity of the eradication therapy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 40mg/day 7days
Interventions/Control_2 Proton pump inhibitor
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
15 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria patients with helicobacter pylori infection
Key exclusion criteria none
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuzo Murai
Organization Onaka Clinic
Division name Department of gastroenterology
Zip code
Address 12-12 Asahicho Hachiouji-shi Tokyo JAPAN
TEL 042-644-1127
Email murai@m-onaka.com

Public contact
Name of contact person
1st name
Middle name
Last name Ryuzo Murai
Organization Onaka Clinic
Division name Department of gastroenterology
Zip code
Address 12-12 Asahicho Hachiouji-shi Tokyo JAPAN
TEL 042-644-1127
Homepage URL
Email murai@m-onaka.com

Sponsor
Institute Onaka Clinic
Institute
Department

Funding Source
Organization Onaka Clinic
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
Address
Tel
Email

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
2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The success rate of vonoprazan-based triple thearpy was 91.7% at the primary eradication compare to 80.9% with PPI. It is significant better result.

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 Terminated
Date of protocol fixation
2015 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 22 Day
Last modified on
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026328

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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