UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024172 |
|---|---|
| Receipt number | 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 07:31:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Japan |
Condition
Condition
H. pylori infection associated gastritis
Classification by specialty
| Medicine in general | Gastroenterology |
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
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.
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.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsushige Sugimoto |
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
sugimo@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsushige Sugimoto |
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 or person
Institute
Shiga University of Medical Science Hospital
Institute
Department
Personal name
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
| 2016 | Year | 10 | Month | 01 | Day |
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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 30 | Day |
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 09 | Month | 26 | Day |
Last modified on
| 2017 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027827
