UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021041 |
|---|---|
| Receipt number | R000024280 |
| Scientific Title | A study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitis |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2019/08/20 23:31:16 |
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Basic information
Public title
A study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitis
Acronym
A study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitis
Scientific Title
A study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitis
Scientific Title:Acronym
A study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitis
Region
| Japan |
Condition
Condition
Eosinophilic esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of vonoprazan on EoE who is resistant to initial PPI therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of esophageal eosinophilia after administration for 2 months
Key secondary outcomes
symptom improvement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of Vonoprazan (20mg/day for 2 months)
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
Patients with EoE who are resistant to initial PPI therapy
Key exclusion criteria
1)Patients with advanced malignant disease
2)Patients who are administrated the drug which affects their condition
3)Patients who are not eligible for participation judged by a resercher
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Norihisa |
| Middle name | |
| Last name | Ishimura |
Organization
Shimane University Faculty of Medicine
Division name
Second department of Internal Medicine
Zip code
693-8501
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 Faculty of Medicine
Division name
Second department of Internal Medicine
Zip code
693-8501
Address
89-1, Enya-cho, Izumo, Shimane
TEL
0853-20-2190
Homepage URL
ishimura@med.shimane-u.ac.jp
Sponsor or person
Institute
Second department of Internal Medicine, Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second department of Internal Medicine, Shimane University Faculty 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
| 2016 | Year | 02 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 15 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024280
