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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022766
Receipt No. R000026232
Scientific Title Eradication of H. Pylori With the Regimen Individualized Susceptibility of H. Pylori to Clarithromycin Determined by the Mutation of 23S rRNA of H. Pylori
Date of disclosure of the study information 2016/07/01
Last modified on 2018/06/18

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Basic information
Public title Eradication of H. Pylori With the Regimen Individualized Susceptibility of H. Pylori to Clarithromycin Determined by the Mutation of 23S rRNA of H. Pylori
Acronym Eradication of H. Pylori Therapy Individualized by the Mutation of 23S rRNA of H. Pylori (EHR)
Scientific Title Eradication of H. Pylori With the Regimen Individualized Susceptibility of H. Pylori to Clarithromycin Determined by the Mutation of 23S rRNA of H. Pylori
Scientific Title:Acronym Eradication of H. Pylori Therapy Individualized by the Mutation of 23S rRNA of H. Pylori (EHR)
Region
Japan

Condition
Condition patients infected with H. pylori
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the clinical efficacy of tailored regimens based on the mutation of H. pylori which is related the resistance to clarithromycin
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Eradication rates of H. pylori is assessed bythe 13C-urea breath test performed at 1 month after the therapy.
Key secondary outcomes interview on the adverse events during the treatment, such as diarrhea, loose stool, abdominal pain and allergic reactions.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 During the gastroscopy, gastric mucus samples are collected, from which DNA is extracted. The DNA samples are subjected the full-auto SNP analyzer and the from A to G mutation of 23s rRNA of H. pylori at the positions of 2142 and 2143 is measured. When the mutation is detected, patients are diagnosed to be infected with clarithromycin-resistant strains of H. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + metronidazole 250 mg bid for 1 week. When the mutation is not detected, patients are considered to be infected with clarithromycin-sensitive strains of H. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + clarithromycin 200 mg bid for 1 week. The success or failure of eradication was determined based on the 13C-urea breath test performed 1 month after the therapy. The total eradication rates with this strategy was compared with that by the standard regimen in Japan performed in the same period of the study.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients infected with H. pylori are invited to the study.
Patients not allergic to the any of the drugs used for eradication of H. pylori.
Patients who has agreed to participate to the study.
Key exclusion criteria Patients allergic to the any of the drugs used for eradication of H. pylori.
Patients who do not agree to the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Furuta
Organization Hamamatsu University School of Medicine
Division name Center for Clinical Research
Zip code
Address 1-20-1, Handayama, Higashi-Ku, Hamamatsu
TEL 053-435-2850
Email furuta@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahisa Furuta
Organization Hamamatsu University School of Medicine
Division name Center for Clinical Research
Zip code
Address 1-20-1, Handayama, Higashi-Ku, Hamamatsu
TEL 053-435-2850
Homepage URL
Email furuta@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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 07 Month 01 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
Under progression
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 Preinitiation
Date of protocol fixation
2016 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 04 Month 15 Day
Date trial data considered complete
2018 Year 05 Month 31 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 16 Day
Last modified on
2018 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026232

Research Plan
Registered date File name
2016/06/28 ☆(4)研究計画書2016.03.24.R2.doc

Research case data specifications
Registered date File name
2016/06/28 (13)23srRNA症例報告書(CRF)R2.docx

Research case data
Registered date File name


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