UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of adverse events in long-term administration of vonoprazan for patients with gastroesophageal reflux disease
Title of the study (Brief title)	Investigation of adverse events in long-term administration of vonoprazan
Region	Japan

Condition
Condition	Gastroesophageal reflux disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of adverse events in long-term administration of vonoprazan for patients with gastroesophageal reflux disease.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of malignant tumor.
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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with gastroesophageal reflux disease having possibility of taking vonoprazan for long-term.
Key exclusion criteria	The patients having contraindication of vonoprazan administratioon.
Target sample size

Research contact person
Name of lead principal investigator	Hisatsugu Noda
Organization	Aichi medical university school of medicine
Division name	gastroenterology
Address	1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL	0561-62-3311
Email	bisaipan@aichi-med-u.ac.jp

Public contact
Name of contact person	Hisatsugu Noda
Organization	Aichi medical university school of medicine
Division name	gastroenterology
Address	1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL	0561-62-3311
Homepage URL
Email	bisaipan@aichi-med-u.ac.jp

Sponsor
Institute	Aichi medical university school of medicine
Institute
Department

Funding Source
Organization	Aichi medical 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)

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 03 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 03 Month 09 Day
Anticipated trial start date	2016 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Cohort study All the members who were equal to criteria for selection in the patients who consulted our institution in March, 2019 from March, 2016

Management information
Registered date	2016 Year 03 Month 10 Day
Last modified on	2017 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024699