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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024290
Receipt No. R000027979
Scientific Title The study of H.pylori third line eradication therapy using Vonoprazan
Date of disclosure of the study information 2016/10/05
Last modified on 2019/06/04

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Basic information
Public title The study of H.pylori third line eradication therapy using Vonoprazan
Acronym The study of H.pylori third line eradication therapy using Vonoprazan
Scientific Title The study of H.pylori third line eradication therapy using Vonoprazan
Scientific Title:Acronym The study of H.pylori third line eradication therapy using Vonoprazan
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Related study with eradication results,antimicrobial drug resisutance and H.pylori gene in H.pylori third line eradication therapy and to evaluate safety
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Related study with eradication results,antimicrobial drug resisutance and H.pylori gene in H.pylori third line eradication therapy
Key secondary outcomes To evaluate safety of H.pylori third line eradication therapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 vonopurazan+metoronidazole(MNZ)+sitafloxacin(STFX)
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 First line eradication(PPI+AMPC+CAM)and second line eradication(PPI+AMPC+MNZ)failure patients with H.pylori infection who want to take eradication treatment. Patients who give a written informed consent.
Key exclusion criteria Pregnancy or lactation. Past history of allergy for the drugs used in this therapy . Sever liver dysfunction, sever renal dysfunction, sever heart dysfunction. Patients who are disqualified for the sutdy by physicians.

Target sample size 10

Research contact person
Name of lead principal investigator
1st name Inoue
Middle name
Last name Syuji
Organization National Hospital Organization National Kochi Hospital
Division name gstroenterology
Zip code 780-8507
Address 1-2-25, Asakuranishimachi, Kochi, 780-8077, Japan
TEL 088-844-3111
Email inoue.shuji.cs@mail.hosp.go.jp

Public contact
Name of contact person
1st name Inoue/Eguchi
Middle name
Last name Syuji / Sizuka
Organization National Hospital Organization National Kochi Hospital
Division name gstroenterology
Zip code 780-8507
Address 1-2-25, Asakuranishimachi, Kochi, 780-8077, Japan
TEL 088-844-3111
Homepage URL
Email inoue.shuji.cs@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization National Kochi Hospital
gstroenterology
Institute
Department

Funding Source
Organization National Hospital Organization National Kochi Hospital
gstroenterology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kochi University medical school
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization National Kochi Hospital
Address 1-2-25, Asakuranishimachi, Kochi, 780-8077, Japan
Tel 088-844-3111
Email inoue.shuji.cs@mail.hosp.go.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 独立行政法人国立病院機構高知病院
高知大学医学部病態情報診断学教室

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 05 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 Completed
Date of protocol fixation
2016 Year 09 Month 16 Day
Date of IRB
2018 Year 09 Month 13 Day
Anticipated trial start date
2016 Year 10 Month 17 Day
Last follow-up date
2017 Year 06 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 10 Month 04 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027979

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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