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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029686
Receipt No. R000033919
Scientific Title the third-line rescue therapy with P-CAB for H. pylori infection
Date of disclosure of the study information 2017/10/24
Last modified on 2017/10/24

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Basic information
Public title the third-line rescue therapy with P-CAB for H. pylori infection
Acronym the third-line rescue therapy
Scientific Title the third-line rescue therapy with P-CAB for H. pylori infection
Scientific Title:Acronym the third-line rescue therapy
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the utility by the investigation of the eradication rate and the frequency of adverse drug reactions
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the eradication rate of the third-line rescue therapy
Key secondary outcomes

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 X2/day, amoxicillin500mg X4 (or metronidazole 250mg X2)/day, sitafloxacin100mg X2/day for 1 week
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 the patients with failure of first and second-line eradication treatments for H. pylori infection, or adverse reactions of these treatments.
Key exclusion criteria patients with severe liver diseases,
patients taking atazanavir sulfate,
and so on.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunari Nakamoto
Organization University of Fukui Hospital
Division name Department of Gastroenterology
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan 910-1193
TEL 0776-61-8351
Email nakamoto-med2@med.u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Suto
Organization University of Fukui Hospital
Division name Department of Gastroenterology
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan 910-1193
TEL 0776-61-8351
Homepage URL
Email hrykstu@u-fukui.ac.jp

Sponsor
Institute University of Fukui Hospital
Institute
Department

Funding Source
Organization University of Fukui Hospital
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
2017 Year 10 Month 24 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 Open public recruiting
Date of protocol fixation
2015 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 17 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
2017 Year 10 Month 24 Day
Last modified on
2017 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033919

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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