UMIN-CTR Clinical Trial

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
Email	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
Email	ishimura@med.shimane-u.ac.jp

Sponsor
Institute	Second department of Internal Medicine, Shimane University Faculty of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024280