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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025765
Receipt No. R000029638
Scientific Title A pilot study of Susceptibility testing based Fourth-line Helicobacter pylori eradication therapy
Date of disclosure of the study information 2017/01/22
Last modified on 2017/01/20

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Basic information
Public title A pilot study of Susceptibility testing based Fourth-line Helicobacter pylori eradication therapy
Acronym Susceptibility based Fourth-line eradication
Scientific Title A pilot study of Susceptibility testing based Fourth-line Helicobacter pylori eradication therapy
Scientific Title:Acronym Susceptibility based Fourth-line eradication
Region
Japan

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

Objectives
Narrative objectives1 To varify the efficacy and safety of susceptibility testing based fourth-line two-weeks Helicobacter pylori eradication therapy with vonoprazan, amoxicillin, clarithromycin and metronidazole.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Eradication rate assessed by urea breath test more than 8 weeks after treatment
Key secondary outcomes Safety evaluated by side effects questionnaire filled by patients

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
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 500mg qid
Clarithromycin 400mg bid
Metronidazole 250mg bid
2 weeks
This regimen is used with modification based on susceptibility testing.
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 A patient with Helicobacter pylori infection failed for first, second (one week triple therapy with acid suppressant and amoxicillin and clarithromycin or metronidazole) and sitafloxacin based third line eradication .
A patient who was diagnosed for Helicobacter pylori infection by urea breath test or Helicobacter pylori stool antigen test.
A patient who can perform urea breath test after 8 weeks from treatment completion.
A patient who give a written informed consent.
Key exclusion criteria A patient who don't agree for endoscopy and susceptible testing as own expense medical care before eradication therapy.
Past history of allergy or side effect requiring treatment for the drugs used in this study.
Pregnancy or lactation. A patient with brain and spinal cord disease. A patient with infectious mononucleosis. Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. Patients who are disqualified for the study by physicians.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Maeda
Organization Yokohama City University Hospital
Division name Gastroenterology
Zip code
Address Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL 045-261-5656
Email smaeda@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soichiro Sue
Organization Yokohama City University Hospital
Division name Gastroenterology
Zip code
Address Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL 045-261-5656
Homepage URL
Email ssue@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization Yokohama City University (Basic research expenditures)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 01 Month 22 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
2016 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 22 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 01 Month 20 Day
Last modified on
2017 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029638

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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