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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025801
Receipt No. R000029648
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
Date of disclosure of the study information 2017/01/24
Last modified on 2017/01/23

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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
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 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
2017 Year 01 Month 23 Day


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

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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