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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022963
Receipt No. R000026374
Scientific Title Comparison of Dual Amoxicillin/Vonoprazan Therapy and Triple Vonoprazan/Amoxicillin/Clarithromycin or Metronidazole Therapy for H. Pylori Eradication
Date of disclosure of the study information 2016/07/10
Last modified on 2019/03/31

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Basic information
Public title Comparison of Dual Amoxicillin/Vonoprazan Therapy and Triple Vonoprazan/Amoxicillin/Clarithromycin or Metronidazole Therapy for H. Pylori Eradication
Acronym Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication
Scientific Title Comparison of Dual Amoxicillin/Vonoprazan Therapy and Triple Vonoprazan/Amoxicillin/Clarithromycin or Metronidazole Therapy for H. Pylori Eradication
Scientific Title:Acronym Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication
Region
Japan

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

Objectives
Narrative objectives1 To compare the eradication rate of the dual therapy with vonoprzan and amoxicillin with that of the triple VPZ/AMPC/CAM therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes eradication rate of H. pylori

Success or failure of eradication is assessed by thr 13C-urea breath test at 4 - 8 weeks after the eradication therapy
Key secondary outcomes Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Triple therapy with Vonoprazan,
amoxicillin and clatrithromycin
Interventions/Control_2 Dual therapy with vonoprazan and amoxicillin
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients infected with H. pylori
Patients not allergic to any of drugs used in the eradication therapy
Patients from whom IC has been obtained
Key exclusion criteria Patients uninfected with H. pylori
Patients who have ever failed in eradication more than two times.
Patients from whom IC cannot be obtained
Patients considered not eligible to the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takahisa
Middle name
Last name Furuta
Organization Hamamatsu University School of Medicine
Division name Center for Clinical Research
Zip code 4313192
Address 1-20-1, Handayama, HigashiKu, Hamamatsu, 431-3192, Japan
TEL 053-435-2850
Email furuta@hama-med.ac.jp

Public contact
Name of contact person
1st name Takahisa
Middle name
Last name Furuta
Organization Hamamatsu University School of Medicine
Division name Center for Clinical Research
Zip code 4313192
Address 1-20-1, Handayama, HigashiKu, Hamamatsu, 431-3192, Japan
TEL 053-435-2850
Homepage URL
Email furuta@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Comity of Hamamatsu University School of Medicine
Address 1-20-1, Handama, Higashiku, Hamamatsu
Tel 0534352111
Email kenkyo@hama-med.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 浜松医科大学付属病院

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 10 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
On going
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
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No troubles have happened.

Management information
Registered date
2016 Year 07 Month 01 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026374

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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