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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024172 |
Receipt No. | R000027827 |
Scientific Title | Influenced factor for outcome of H. pylori eradication therapy: retrospective study |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2017/01/30 |
Basic information | ||
Public title | Influenced factor for outcome of H. pylori eradication therapy: retrospective study | |
Acronym | Association with H. pylori eradication and CYP3A4/5 type | |
Scientific Title | Influenced factor for outcome of H. pylori eradication therapy: retrospective study | |
Scientific Title:Acronym | Association with H. pylori eradication and CYP3A4/5 type | |
Region |
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Condition | |||
Condition | H. pylori infection associated gastritis | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | YES |
Objectives | |
Narrative objectives1 | To clarify influenced factor of outcome of H. pylori eradication therapy using PPI or vonprazan (alcohol, smoking, CYP2C19 genotype, CYP3A4/5 genotype, compliance and susceptibility to antimicrobial agents) |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Eradication rate of H. pylori infection |
Key secondary outcomes | (1) incidence rate of adverse effects
(2) influence of CYP2C19 genotypes for outcome of eradication therapy (3) influence of CYP3A4/5 genotypes for outcome of eradication therapy (4) influence of susceptibility to antimicrobial agents for outcome of eradication therapy |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. patients eradicated H. pylori form April 2013 to July 2016 in Shiga University of Medical Science Hospital.
2. patients received informed consent previously for genotyping of CYP2C19 and drug-metabolized enzyme genes. |
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Key exclusion criteria | 1. Without informed consent
2. without detail clinical data, such as kinds of eradication regimen, age, sex, side effects, outcome of eradication therapy, severity of gastric mucosal atrophy, status of GERD, peptic ulcer and gastric cancer, smoking, alcohol, and CYP2C19 genotype status. |
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Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Shiga University of Medical Science Hospital
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Division name | Division of Digestive Endoscopy | ||||||
Zip code | |||||||
Address | Seta Tsukinowa-cho, Otsu, Shiga, JAPAN, 520-2192 | ||||||
TEL | 077-548-2618 | ||||||
sugimo@belle.shiga-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Shiga University of Medical Science Hospital | ||||||
Division name | Division of Digestive Endoscopy | ||||||
Zip code | |||||||
Address | Seta Tsukinowa-cho, Otsu, Shiga, JAPAN, 520-2192 | ||||||
TEL | 077-548-2618 | ||||||
Homepage URL | |||||||
sugimo@belle.shiga-med.ac.jp |
Sponsor | |
Institute | Shiga University of Medical Science Hospital |
Institute | |
Department |
Funding Source | |
Organization | Shiga University of Medical Science Hospital |
Organization | |
Division | |
Category of Funding Organization | Other |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | None |
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=R000027827 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |