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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032109
Receipt No. R000036631
Scientific Title Sequential therapy with vonoprazan, amoxicillin 7 days and vonoprazan, metronidazole, and sitafloxacin 7 days versus triple therapy with vonoprazan, amoxicillin, and metronidazole 7days for early age Helicobacter pylori infection: a multicentre, open-label, randomised trial
Date of disclosure of the study information 2018/04/06
Last modified on 2018/09/05

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Basic information
Public title Sequential therapy with vonoprazan, amoxicillin 7 days and vonoprazan, metronidazole, and sitafloxacin 7 days versus triple therapy with vonoprazan, amoxicillin, and metronidazole 7days for early age Helicobacter pylori infection: a multicentre, open-label, randomised trial
Acronym RCT comparing VA-VMS sequential and VAM HP eradication for Early age patients
Scientific Title Sequential therapy with vonoprazan, amoxicillin 7 days and vonoprazan, metronidazole, and sitafloxacin 7 days versus triple therapy with vonoprazan, amoxicillin, and metronidazole 7days for early age Helicobacter pylori infection: a multicentre, open-label, randomised trial
Scientific Title:Acronym RCT comparing VA-VMS sequential and VAM HP eradication for Early age patients
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 sequential therapy with vonoprazan-amoxicillin and vonoprazan-metronidazole-sitafloxacin and triple therapy with vonoprazan-amoxicillin-metronidazole as the first-line treatment for Helicobacter pylori positive patients less than 40 year-old.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Eradication rate assessed by stool antigen test of Helicobacter pylori more than 8 weeks after treatment
Key secondary outcomes Adverse event 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 A 14-day sequential therapy conaining vonoprazan and amoxicillin for 7 days followed by vonoprazan, metronidazole and sitafloxacin for 7 days
: Vonoprazan 20mg bid
Amoxicillin 750mg bid
7 days
followed by
Vonoprazan 20mg bid
Metronidazole 250mg bid
Sitafloxacin 100mg bid
7 days
(Total 14 days)
Interventions/Control_2 A 7-day triple therapy with vonoprazan, amoxicillin, and metronidazole
:Vonoprazan 20mg 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
40 years-old >=
Gender Male and Female
Key inclusion criteria (1) A patient with Helicobacter pylori infection.
(2) A patient who can perform stool antigen test of Helicobacter pylori after 8 weeks from treatment completion.
(3)A patient who give a written informed consent.
Key exclusion criteria (1) A patient with history of Helicobacter pylori eradication.
(2) Pregnancy.
(3) Lactation.
(4) Patients allergic to penicillin.
(5) Past history of allergy for the drugs used in this study.
(6) A patient with brain and spinal cord disease.
(7) A patient with infectious mononucleosis.
(8) Severe liver dysfunction, serere renal dysfunction, severe heart dysfunction.
(9) Patient who is disualified for the study by physicians.
Target sample size 190

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 045-787-2326
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 045-787-2326
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

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
2018 Year 04 Month 06 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
2018 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 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
2018 Year 04 Month 04 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036631

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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