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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025252
Receipt No. R000028821
Scientific Title Potassium-competitive acid blocker-based third-line triple therapy in Helicobacter Pylori eradication
Date of disclosure of the study information 2016/12/13
Last modified on 2018/06/15

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Basic information
Public title Potassium-competitive acid blocker-based third-line triple therapy in Helicobacter Pylori eradication
Acronym Potassium-competitive acid blocker-based third-line triple therapy in Helicobacter Pylori eradication
Scientific Title Potassium-competitive acid blocker-based third-line triple therapy in Helicobacter Pylori eradication
Scientific Title:Acronym Potassium-competitive acid blocker-based third-line triple therapy in Helicobacter Pylori eradication
Region
Japan

Condition
Condition chronic gastritis with H.Pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the eradication rate of P-CAB-based triple therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the antimicrobial susceptibility test and eradication rate after 8weeks
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 P-cab 20mg bid + MNZ 250mg bid + STFX 100mg bid x 7days
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 2nd-line eradication failure or penicillin allergy
Key exclusion criteria < 20 years old
Patients with severe heart desease, renal dysfunction or liver dysfunction
Patients with allergy for 3rd-eradication drugs
Patients using anti-coagulation or anti-platelet drugs
Pregnants or patient who want pregnancy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Mizuta
Organization Kochi medical school
Division name Department of gastroenterology and hepatology
Zip code
Address Kohasu, Okou-town, Nankoku-city
TEL 088-880-2333
Email mizutahi@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Mizuta
Organization Kochi medical school
Division name Department of gastroenterology and hepatology
Zip code
Address Kohasu, Okou-town, Nankoku-city
TEL 088-880-2333
Homepage URL
Email mizutahi@kochi-u.ac.jp

Sponsor
Institute Kochi medical school
Institute
Department

Funding Source
Organization Kochi medical school
Organization
Division
Category of Funding Organization Other
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 12 Month 13 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
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 No longer recruiting
Date of protocol fixation
2015 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2018 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028821

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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