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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018836
Receipt No. R000021740
Scientific Title Exploratory clinical trial of the new 4th line Helicobacter pylori eradication therapy using vonoprazan
Date of disclosure of the study information 2015/09/01
Last modified on 2019/03/30

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Basic information
Public title Exploratory clinical trial of the new 4th line Helicobacter pylori eradication therapy using vonoprazan

Acronym Efficacy of the new salvage line Helicobacter pylori eradication therapy using vonoprazan
Scientific Title Exploratory clinical trial of the new 4th line Helicobacter pylori eradication therapy using vonoprazan

Scientific Title:Acronym Efficacy of the new salvage line Helicobacter pylori eradication therapy using vonoprazan
Region
Japan

Condition
Condition Helicobacter infection with previous eradication failure

Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of the new third line therapy using vonoprazan

Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Eradication rate of Helicobacter pylori 8-12 wks after treatment

Key secondary outcomes Rate of adverse events


Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Vonoprazan 20mg bid
Amoxicillin 750mg bid
Rifabutin 150mg bid
Interventions/Control_2
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 Patients with three eradication failures by clarithromycin, metronidazole and sitafloxacin based regimen

Key exclusion criteria Pregnancy
Lactation
Allergy for the study drugs
Severe major organ dysfunction
Patients who are judged by the investigators to be inappropriate for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuo Yamada
Organization The University of Tokyo

Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL +81-3-3815-5411
Email yamada-a@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuo Yamada
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL +81-3-3815-5411
Homepage URL
Email yamada-a@umin.ac.jp

Sponsor
Institute Department of Gastroenterology, The University of Tokyo

Institute
Department

Funding Source
Organization Department of Gastroenterology, The University of Tokyo

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
2015 Year 09 Month 01 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
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
2015 Year 07 Month 30 Day
Date of IRB
2015 Year 08 Month 04 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2019 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 27 Day
Last modified on
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021740

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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