UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial comparing Vonoprazan, Amoxicillin, Metronidazole triple therapy and Rabeprazole, Amoxicillin, Metronidazole triple therapy as a second-line eradication of Helicobacter pylori
Acronym	RCT comparing VAM and RAM HP eradication as second-line
Scientific Title	A randomized controlled trial comparing Vonoprazan, Amoxicillin, Metronidazole triple therapy and Rabeprazole, Amoxicillin, Metronidazole triple therapy as a second-line eradication of Helicobacter pylori
Scientific Title:Acronym	RCT comparing VAM and RAM HP eradication as second-line
Region	Japan

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

Objectives
Narrative objectives1	To compare the efficacy and safety between Vonoprazan/Amoxicillin/Metronidazole and Rabeprazole/Amoxicillin/Metronidazole 7 day triple therapy for second-line Helicobacter pylori eradication therapy
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 effect questionnaire filled by patients

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vonoprazan 20mg bid Amoxicillin 750mg bid Metronidazole 250mg bid 7 days
Interventions/Control_2	Rabeprazole 10mg bid Amoxicillin 750mg bid Metronidazole 250mg bid 7 days
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 who failed first-line eradication therapy with Vonoprazan, Amoxicillin and Clarithromycin. A patient who can do eradication therapy as second time(second-line) in this study. A patient who was diagnosed for Helicobacter pylori infection and failure of first-line eradication 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 has eradication history except triple therapy with Vonoprazan, Amoxicillin and Clarithromycin. Pregnancy or lactation. Past history of allergy for the drugs used in this study. A patient with brain and spinal cord disease. A patient with infectious mononucleosis. Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. Patient who is disqualified for the study by physicians.
Target sample size	80

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 Ethics Committee
Address	Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa
Tel	045-370-7627
Email	rinri@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 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	2016 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date	2017 Year 01 Month 24 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 23 Day
Last modified on	2020 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029648