UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033821
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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)

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
URL(English) https://upload.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


Contact us.