UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026704 |
|---|---|
| Receipt number | R000030656 |
| Scientific Title | A study investigating the effect of CYP2C19 polymorphism on the therapeutic efficacy in patients with eosinophilic esophagitis |
| Date of disclosure of the study information | 2017/03/27 |
| Last modified on | 2023/03/31 17:01:45 |
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Basic information
Public title
A study investigating the effect of CYP2C19 polymorphism on the therapeutic efficacy in patients with eosinophilic esophagitis
Acronym
CYP2C19 polymorphism in patients with eosinophilic esophagitis
Scientific Title
A study investigating the effect of CYP2C19 polymorphism on the therapeutic efficacy in patients with eosinophilic esophagitis
Scientific Title:Acronym
CYP2C19 polymorphism in patients with eosinophilic esophagitis
Region
| Japan |
Condition
Condition
Eosinophilic esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify whether CYP2C19 polymorphism iis associated with the therapeutic effect of proton pump inhibitor in patients with eosinophilic esophagitis
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between CYP2C19 polymorphism and secondary failure on proton pump inhibitor treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
presence or absence of improvement of eosinophilic infiltration 2 month after administration of proton pump inhibitor
Key secondary outcomes
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 who are diagnosed with eosinophilic esophagitis at our hospital
2) Patients who are obtained informed consent prior the study
Key exclusion criteria
1) Patients who are not treated by proton pump inhibitor or those who are not scheduled to treat by proton pump inhibitor
2) Patients who are judged inadequate for this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Norihisa |
| Middle name | |
| Last name | Ishimura |
Organization
Shimane University School of Medicine
Division name
Department of Internal Medicine II
Zip code
6938501
Address
89-1, Enya-cho, Izumo, Shimane
TEL
0853-20-2190
ishimura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihisa |
| Middle name | |
| Last name | Ishimura |
Organization
Shimane University School of Medicine
Division name
Department of Internal Medicine II
Zip code
6938501
Address
89-1, Enya-cho, Izumo, Shimane
TEL
0853-20-2190
Homepage URL
ishimura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane 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
Clinical Research Center, Shimane University Hospital
Address
89-1 Enya-cho, Izumo, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-u.ac.jp
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
| 2017 | Year | 03 | Month | 27 | 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
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
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CYP2C19 polymorphism is measured in patients with eosinophilic esophagitis. Then, the relationship between CYP2C19 polymorphism and therapeutic effect of proton pump inhibitor is evaluated.
Management information
Registered date
| 2017 | Year | 03 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030656
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
