UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022235 |
|---|---|
| Receipt number | R000025611 |
| Scientific Title | Third line H. pylori eradication therapy with sitafloxacin, amoxicillin and vonaprazan |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2022/11/12 10:41:51 |
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Basic information
Public title
Third line H. pylori eradication therapy with sitafloxacin, amoxicillin and vonaprazan
Acronym
Third line H. pylori eradication therapy with sitafloxacin, amoxicillin and vonaprazan
Scientific Title
Third line H. pylori eradication therapy with sitafloxacin, amoxicillin and vonaprazan
Scientific Title:Acronym
Third line H. pylori eradication therapy with sitafloxacin, amoxicillin and vonaprazan
Region
| Japan |
Condition
Condition
H. pylori-positve patients after the 2nd line eradication failure
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaliation of the efficacy and safety of STFX+AMPC+Pcab 7days regimen
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The efficacy of H. pylori eradication
Key secondary outcomes
adverse events
MIC of STFX,AMPC, 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., amoxicillin 2.0g, q.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 with informed consent
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
1608582
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
16508582
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
Other
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
03-3353-1211
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
114
Results
Even for gyrA mutation positive H.pylori, eradication rate of 7-day VAS regimen achieved 89.7% of successful eradication, which is obviously higher than 10-day EAS regimen.
D91 gyrA mutation-positive H. pylori strains were completely eradicated by 7-day VAS regimen. This finding is important in terms of sufficiently reducing the risk of acquiring double mutations.
Results date posted
| 2022 | Year | 11 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cases of tertiary eradication of H. pylori
Participant flow
Recruitment after secondary sterilisation failure.
Adverse events
Adverse events were reported in 38.7% of cases, 1 stopped treatment due to eruption, diarrhea and headache.
Outcome measures
Eradication rate
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
| 2019 | Year | 09 | Month | 30 | 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
| 2022 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025611
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
