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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022154
Receipt No. R000025525
Scientific Title A tailor-made eradication for the third-line therapy to Helicobacter pylori infection.
Date of disclosure of the study information 2016/05/01
Last modified on 2020/05/08

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Basic information
Public title A tailor-made eradication for the third-line therapy to Helicobacter pylori infection.
Acronym A tailor-made eradication therapy
Scientific Title A tailor-made eradication for the third-line therapy to Helicobacter pylori infection.
Scientific Title:Acronym A tailor-made eradication therapy
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of the tailor-made eradication therapy for the patients who failed twice PPI-based eradication therapies.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Eradication success rate is measured 2
months after eradication therapy.
Key secondary outcomes Safety is evaluated with the adverse event analysis during the therapy.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A proton pump inhibitor and two antibiotics are prescribed.
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 who are positive for H. pylori after twice standard eradication therapies.
Key exclusion criteria Those who do not want to undergo eradication therapy anymore.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Shigemi
Middle name
Last name Nakajima
Organization Japan Community Health care Organization Shiga Hospital
Division name Department of General Medicine
Zip code 520-0846
Address 16-1 Fujimidai, Otsu city, Shiga 520-0846, Japan
TEL 077-537-3101
Email shigemin@rainbow.plala.or.jp

Public contact
Name of contact person
1st name Shigemi
Middle name
Last name Nakajima
Organization JCHO Shiga Hospital
Division name Department of General Medicine
Zip code 520-0846
Address 16-1 Fujimidai, Otsu city, Shiga 520-0846, Japan
TEL 077-537-3101
Homepage URL
Email shigemin@rainbow.plala.or.jp

Sponsor
Institute Department of General Medicine, JCHO Shiga Hospital
Institute
Department

Funding Source
Organization None
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 JCHO Shiga Hospital
Address 16-1 Fujimidai, Otsu, Shiga, Japan
Tel 077-537-3101
Email chiken@shiga.jcho.go.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 JCHO滋賀病院(滋賀県)

Other administrative information
Date of disclosure of the study information
2016 Year 05 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 47
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Manuscript is now under writing.
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
2007 Year 09 Month 01 Day
Date of IRB
2016 Year 02 Month 01 Day
Anticipated trial start date
2007 Year 09 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 12 Month 31 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 30 Day
Last modified on
2020 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025525

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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