UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022766 |
|---|---|
| Receipt number | 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 | 2019/12/19 09:30:57 |
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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
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
furuta@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
0
Results
Under progression
Results date posted
| 2019 | Year | 12 | Month | 19 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Delay
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
| 2019 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.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 |
