UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022922 |
|---|---|
| Receipt number | 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 17:22:52 |
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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
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
furuta@hama-med.ac.jp
Sponsor or person
Institute
Ministry of health, labor and welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026415
