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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | patients infected with H. pylori | |
Classification by specialty |
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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.
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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 |
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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 | ||
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Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |