UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022963 |
|---|---|
| Receipt number | 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 | 2020/01/03 17:00:22 |
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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
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
furuta@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
Ethics Comity of Hamamatsu University School of Medicine
Address
1-20-1, Handama, Higashiku, Hamamatsu
Tel
0534352111
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
| 2015 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 01 | Day |
Last modified on
| 2020 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026374
