UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060484 |
|---|---|
| Receipt number | R000069194 |
| Scientific Title | Comparative efficacy and safety of vonoprazan- and rabeprazole-based triple therapy in second-line Helicobacter pylori eradication |
| Date of disclosure of the study information | 2026/01/27 |
| Last modified on | 2026/01/27 14:44:36 |
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Basic information
Public title
Comparative efficacy and safety of vonoprazan- and rabeprazole-based triple therapy in second-line Helicobacter pylori eradication
Acronym
Comparative efficacy and safety of vonoprazan- and rabeprazole-based triple therapy in second-line Helicobacter pylori eradication
Scientific Title
Comparative efficacy and safety of vonoprazan- and rabeprazole-based triple therapy in second-line Helicobacter pylori eradication
Scientific Title:Acronym
Comparative efficacy and safety of vonoprazan- and rabeprazole-based triple therapy in second-line Helicobacter pylori eradication
Region
| Japan |
Condition
Condition
H. pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of second-line H. pylori eradication
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Second-line eradication rate
Key secondary outcomes
Treatment emergent adverse events
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-based triple therapy in second-line H. pylori eradication
Interventions/Control_2
Rabeprazole-based triple therapy in second-line H. pylori eradication
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who received VPZ-based or RPZ-based triple therapy for second-line H. pylori eradication in Fuyoukai Murakami Hospital from 1 March 2015 to 28 February 2022
Key exclusion criteria
None
Target sample size
92
Research contact person
Name of lead principal investigator
| 1st name | Yusaku |
| Middle name | |
| Last name | Kajihara |
Organization
Fuyoukai Murakami Hospital
Division name
Department of Gastroenterology
Zip code
030-0843
Address
3-3-14 Hamada, Aomori
TEL
+81-17-729-8888
y_kaji2012@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yusaku |
| Middle name | |
| Last name | Kajihara |
Organization
Fuyoukai Murakami Hospital
Division name
Department of Gastroenterology
Zip code
030-0843
Address
3-3-14 Hamada, Aomori
TEL
+81-17-729-8888
Homepage URL
y_kaji2012@yahoo.co.jp
Sponsor or person
Institute
Fuyoukai Murakami Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Fuyoukai Murakami Hospital
Address
3-3-14 Hamada, Aomori
Tel
+81-17-729-8888
y_kaji2012@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
96
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069194
