UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033821
Receipt number R000038576
Scientific Title Study of effectiveness of on-demand therapy using 20mg vonoprazan for NERD (Grade M by revised LA classification) well controlled with a proton pump inhibitor (PPI)
Date of disclosure of the study information 2018/09/01
Last modified on 2019/02/19 17:11:50

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Basic information

Public title

Study of effectiveness of on-demand therapy using 20mg vonoprazan for NERD (Grade M by revised LA classification) well controlled with a proton pump inhibitor (PPI)

Acronym

Usefulness of on-demand therapy using 20mg vonoprazan for NERD (Grade M by revised LA classification)

Scientific Title

Study of effectiveness of on-demand therapy using 20mg vonoprazan for NERD (Grade M by revised LA classification) well controlled with a proton pump inhibitor (PPI)

Scientific Title:Acronym

Usefulness of on-demand therapy using 20mg vonoprazan for NERD (Grade M by revised LA classification)

Region

Japan


Condition

Condition

NERD(Grade M by revised LA classification)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the usefulness of on-demand therapy of taking one 20-mg tablet of vonoprazan only when reflux symptoms occurred for patients who have been diagnosed with NERD (LA classification, Grade M), maintain remission by PPI therapy, are satisfied with the treatment and have an esophageal hiatal hernia smaller than 2cm.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. The overall satisfaction level after 8-week on-demand therapy
2. The gastrin level before breakfast and the number of 20-mg vonoprazan tablets taken before and after on-demand therapy (8 weeks)

Key secondary outcomes



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

On-demand therapy using 20-mg vonoprazan (8 weeks)

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Over 20 years old and younger than 80 years old
2. Both males and females
3. Outpatients
4. Patients who have been diagnosed with NERD (LA classification, Grade M), maintain remission by standard-dose PPI therapy, and satisfied with the treatment, and have an esophageal hiatal hernia smaller than 2cm
5. Patients who understood study, and provided written consent based on their own will

Key exclusion criteria

1. Allergy patients to drugs being studied
2. Patients with critical dysfunction of liver and kidney
3. Patients with malignancy
4.Patints suspected with active infection
5. Pregnant or possibility of being pregnant, and those who are breastfeeding
6. Study participation decided to be contraindicated by the parson in charge

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuhiko Iwakiri

Organization

Nippon Medical School

Division name

Department of Gastroenterology

Zip code


Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Email

k-iwa@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuhiko Iwakiri

Organization

Nippon Medical School

Division name

Department of Gastroenterology

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Homepage URL


Email

k-iwa@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

2018 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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 10 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 12 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 20 Day

Last modified on

2019 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038576


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name