UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022846 |
|---|---|
| Receipt number | R000026328 |
| Scientific Title | Study of Vonoprazan-based triple theary for eradication of helicobacter pylori |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2018/10/12 15:06:10 |
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Basic information
Public title
Study of Vonoprazan-based triple theary for eradication of helicobacter pylori
Acronym
Eradication with Vonoprazan
Scientific Title
Study of Vonoprazan-based triple theary for eradication of helicobacter pylori
Scientific Title:Acronym
Eradication with Vonoprazan
Region
| Japan |
Condition
Condition
gastritis with helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate Vonoprazan-based triple thearpy for helicobacter pylori compare to PPI-based triple thearpy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of the eradication therapy after one month later by urea breath test
Key secondary outcomes
Mortality and morbidity of the eradication therapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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 40mg/day 7days
Interventions/Control_2
Proton pump inhibitor
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with helicobacter pylori infection
Key exclusion criteria
none
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuzo Murai |
Organization
Onaka Clinic
Division name
Department of gastroenterology
Zip code
Address
12-12 Asahicho Hachiouji-shi Tokyo JAPAN
TEL
042-644-1127
murai@m-onaka.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuzo Murai |
Organization
Onaka Clinic
Division name
Department of gastroenterology
Zip code
Address
12-12 Asahicho Hachiouji-shi Tokyo JAPAN
TEL
042-644-1127
Homepage URL
murai@m-onaka.com
Sponsor or person
Institute
Onaka Clinic
Institute
Department
Personal name
Funding Source
Organization
Onaka Clinic
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
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
| 2016 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The success rate of vonoprazan-based triple thearpy was 91.7% at the primary eradication compare to 80.9% with PPI. It is significant better result.
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
Terminated
Date of protocol fixation
| 2015 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 28 | 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
| 2016 | Year | 06 | Month | 22 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026328
