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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022236
Receipt No. 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 2017/09/02

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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
Middle name
Last name Tastuhiro Masaoka
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 35 Shinanomachi, SHinjuku-ku, Tokyo
TEL 03-5363-3790
Email masaoka@z6.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tastuhiro Masaoka
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 35 Shinanomachi, SHinjuku-ku, Tokyo
TEL 03-5363-3790
Homepage URL
Email masaoka@z6.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Others
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
Address
Tel
Email

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
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
2016 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 09 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 05 Month 07 Day
Last modified on
2017 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025613

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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