UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051852 |
|---|---|
| Receipt number | R000059168 |
| Scientific Title | Study of the efficacy of third-line eradication therapy with sitafloxacin in patients who failed Helicibacter pylori eradication. |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2024/06/05 16:50:55 |
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Basic information
Public title
Study of the efficacy of third-line eradication therapy with sitafloxacin in patients who failed Helicibacter pylori eradication
Acronym
Study of the efficacy of third-line eradication therapy with sitafloxacin in patients who failed Helicibacter pylori eradication
Scientific Title
Study of the efficacy of third-line eradication therapy with sitafloxacin in patients who failed Helicibacter pylori eradication.
Scientific Title:Acronym
Study of the efficacy of third-line eradication therapy with sitafloxacin in patients who failed Helicibacter pylori eradication.
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical outcomes of third-line eradication with sitafloxacin in Helicobacter pylori patients who have failed second-line eradication
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of H. pylori eradication in third-line Helicobacter eradication therapy (7-day VPZ-MNZ-SFTX triple therapy)
Key secondary outcomes
Incidence of adverse events
Factors influencing H. pylori eradication failure
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have been confirmed to be unsuccessful in the second-line H. pylori eradication therapy by our hospital or a previous physician, and who have undergone the third-line eradication at our hospital and who have done an eradication determination test.
Key exclusion criteria
(1) Pregnant or lactating patients
(2) Patients with allergy to VPZ, MNZ, or STFX
(3) Patients with severe liver, kidney, or heart dysfunction
(4) Patients whose physician deems inappropriate
(5) Patients who are allergic to penicillin and have used VPZ-MNZ-STFX triple therapy as primary or secondary eradication therapy.
(6) Patients diagnosed with autoimmune gastritis
(7) Patients whose eradication decision could not be confirmed
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Mizukami |
Organization
Faculty of Medicine, Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita, Japan
TEL
097-586-6193
mizkaz0809@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Mizukami |
Organization
Faculty of Medicine, Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita, Japan
TEL
097-586-6193
Homepage URL
mizkaz0809@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Faculty of Medicine, Oita University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, Oita University
Address
1-1, idaigaoka, Hasama, Yufu, Oita, Japan
Tel
097-586-6380
rinrikenkyu@oita-u.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
| 2023 | Year | 08 | Month | 07 | 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
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
| 2023 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research the following.
Age, gender, smoking history, alcohol consumption history, height, weight, medical history, allergy history, H. pylori eradication history, endoscopic findings, treatment (medications), medication compliance rate, eradication decision results, and adverse events.
Management information
Registered date
| 2023 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059168
