UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021419
Receipt number R000024699
Scientific Title Investigation of adverse events in long-term administration of vonoprazan for patients with gastroesophageal reflux disease
Date of disclosure of the study information 2016/03/10
Last modified on 2017/02/03 16:50:43

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Basic information

Public title

Investigation of adverse events in long-term administration of vonoprazan for patients with gastroesophageal reflux disease

Acronym

Investigation of adverse events in long-term administration of vonoprazan

Scientific Title

Investigation of adverse events in long-term administration of vonoprazan for patients with gastroesophageal reflux disease

Scientific Title:Acronym

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

1st name
Middle name
Last name Hisatsugu Noda

Organization

Aichi medical university school of medicine

Division name

gastroenterology

Zip code


Address

1-1 Yazakokarimata, Nagakute, Aichi, Japan

TEL

0561-62-3311

Email

bisaipan@aichi-med-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisatsugu Noda

Organization

Aichi medical university school of medicine

Division name

gastroenterology

Zip code


Address

1-1 Yazakokarimata, Nagakute, Aichi, Japan

TEL

0561-62-3311

Homepage URL


Email

bisaipan@aichi-med-u.ac.jp


Sponsor or person

Institute

Aichi medical university school of medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2016 Year 03 Month 09 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024699


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name