UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022922
Receipt No. R000026415
Scientific Title Comparison of vonoprazan-based dual therapy with amoxicillin and the triple therapy with amoxicillin and clarithromycin for H. Pylori Eradication
Date of disclosure of the study information 2016/07/01
Last modified on 2017/12/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of vonoprazan-based dual therapy with amoxicillin and the triple therapy with amoxicillin and clarithromycin for H. Pylori Eradication
Acronym Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication
Scientific Title Comparison of vonoprazan-based dual therapy with amoxicillin and the triple therapy with amoxicillin and clarithromycin 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 with the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid with those with the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and metronidazole 250 mg bid for 1 week.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes eradication rates of H. pylori
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid for 1 week.
Interventions/Control_2 The dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients infected with H. pylori
Patients who agree to participate to the study
Key exclusion criteria Patients who do not agree to participate to the study
Patients who had ever failed in eradication of H. pylori no less than 2 times.
Patients who are allergic to any of drugs used in this study
Patients who are considered inappropriate to participate to the study by the doctor
Target sample size 100

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

Sponsor
Institute Ministry of health, labor and welfare
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
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1 R15-006
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 01 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
2015 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 28 Day
Last modified on
2017 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026415

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.