UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022236 |
|---|---|
| Receipt number | R000025613 |
| Scientific Title | The efficacy of H. pylori eradication therapy with sitafloxacin-metronidazole-vonaprazan 10 day regimen |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2025/11/13 11:07:24 |
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Basic information
Public title
The efficacy of H. pylori eradication therapy with sitafloxacin-metronidazole-vonaprazan 10 day regimen
Acronym
The efficacy of H. pylori eradication therapy with sitafloxacin-metronidazole-vonaprazan 10 day regimen
Scientific Title
The efficacy of H. pylori eradication therapy with sitafloxacin-metronidazole-vonaprazan 10 day regimen
Scientific Title:Acronym
The efficacy of H. pylori eradication therapy with sitafloxacin-metronidazole-vonaprazan 10 day regimen
Region
| Japan |
Condition
Condition
H. pylori-positve patients after the 2nd line eradication failure or penicillin-allergic patients
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaliation of the efficacy and safety of STFX+MNZ+Pcab 10days regimen
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of H. pylori eradication
Key secondary outcomes
adverse events
MIC of STFX,MNZ, gyaA mutation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
vonaprazan 40mg, b.i.d., metronidazole 500mg b.i.d, sitafloxacin 200 mg, b.i.d.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
H. pylori-positve patients after the 2nd line H. pylori eradication therapy or penicillin-allergic patients
Key exclusion criteria
1. Patients with allergy for quinolones
2. Patients with allergy for PPIs
3. Patients with severe liver injury and/or severe renal damage
4. Pregnancy or possible pregnancy
5. Patients who were recognized as inappropriate for entry
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tastuhiro |
| Middle name | |
| Last name | Masaoka |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
TEL
03-5363-3790
masaoka@z6.keio.jp
Public contact
Name of contact person
| 1st name | Tastuhiro |
| Middle name | |
| Last name | Masaoka |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
TEL
03-5363-3790
Homepage URL
masaoka@z6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical Center, Saiseikai Central Hospital, Keiyu Hospital, Eiju General Hospital, Sano Kosei Hospital, Nippon Kokan Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
88
Results
A total of 88 patients were enrolled in this study between 2016 and 2023, and 73 patients underwent eradication therapy. The eradication rates were 97.2% for the 10-day VMS regimen and 89.5% for the 10-day EMS regimen in the per-protocol analysis (p = 0.138), and 94.5% for the 10-day VMS regimen and 89.5% for the 10-day EMS regimen in the intention-to-treat analysis (p = 0.333).
Results date posted
| 2025 | Year | 11 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Although several reports have described the efficacy of the VMS regimen in patients with penicillin allergy, these studies involved only a small number of cases and did not adequately evaluate antimicrobial susceptibility or gyrA gene mutations that determine quinolone resistance.
Participant flow
We performed eradication therapy using a 10-day regimen of vonoprazan, metronidazole (MTZ), and sitafloxacin (STFX) (10-day VMS) in patients with H. pylori infection who had a penicillin allergy. In all cases, H. pylori strains were isolated and cultured prior to treatment, and antimicrobial susceptibility testing as well as gyrA gene mutation analysis were conducted.
Adverse events
Adverse events were observed in 46.5% of patients receiving the 10-day VMS regimen and in 31.6% of those receiving the 10-day EMS regimen (p = 0.104). Most events were mild diarrhea or loose stools, and symptoms resolved after completion of the eradication regimen.
Outcome measures
Eradication rate, side effects
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 12 | 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 | 05 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025613
