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 |
* 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
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
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
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
