UMIN-CTR Clinical Trial

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 Shin Middle name Last name Maeda
Organization	Yokohama City University Hospital
Division name	Gastroenterology
Zip code	236-0004
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 Soichiro Middle name Last name Sue
Organization	Yokohama City University Hospital
Division name	Gastroenterology
Zip code	236-0004
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	Yokohama City University Certified Institutional Review Board
Address	Fukuura3-9, Kanazawa-ku, Yokohama city, Kanagawa
Tel	045-370-7627
Email	ycu_crb@yokohama-cu.ac.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

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	Completed
Date of protocol fixation	2016 Year 12 Month 16 Day
Date of IRB	2016 Year 12 Month 16 Day
Anticipated trial start date	2017 Year 01 Month 22 Day
Last follow-up date	2021 Year 04 Month 12 Day
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	2022 Year 01 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029638