UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Katsuhiko Iwakiri
Organization	Nippon Medical School
Division name	Department of Gastroenterology
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	k-iwa@nms.ac.jp

Public contact
Name of contact person	Katsuhiko Iwakiri
Organization	Nippon Medical School
Division name	Department of Gastroenterology
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	k-iwa@nms.ac.jp

Sponsor
Institute	Nippon Medical School Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038576