UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027034 |
|---|---|
| Receipt number | R000030992 |
| Scientific Title | Effectiveness of on-demand therapy using 20-mg vonoprozan for patients with mild reflux esophagitis well controlled with a proton pump inhibitor (PPI) |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2017/04/18 13:31:29 |
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Basic information
Public title
Effectiveness of on-demand therapy using 20-mg vonoprozan for patients with mild reflux esophagitis well controlled with a proton pump inhibitor (PPI)
Acronym
Usefulness of on-demand therapy using 20-mg vonoprozan for the management of mild reflux esophagitis
Scientific Title
Effectiveness of on-demand therapy using 20-mg vonoprozan for patients with mild reflux esophagitis well controlled with a proton pump inhibitor (PPI)
Scientific Title:Acronym
Usefulness of on-demand therapy using 20-mg vonoprozan for the management of mild reflux esophagitis
Region
| Japan |
Condition
Condition
Mild reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of 20-mg vonoprazan on-demand therapy for mild reflux esophagitis by administering it orally only when there are acid reflux symptoms (on demand) to patients who have been diagnosed with mild reflux esophagitis (Grade A or B by the Los Angeles classification), maintain remission by standard-dose oral PPI therapy, and are satisfied with the treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.The endoscopic remission rate and overall satisfaction level after 24- and 52-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 (24 and 52 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 (24 and 52 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 mild reflux esophagitis (Grade A or B by the Los Angeles classification), maintain remission by standard-dose oral PPI therapy, are satisfied with the treatment, and have an esophageal hiatal hernia smaller than 2 cm
5. Patients who understood study, and provided written consent based on their own will
Key exclusion criteria
1. Liver and kidney dysfunction
2. Allergy to many kind of drugs
3. Pregnant or possibility of being pregnant, and those who are breastfeeding.
4. Participation in another study within the last 4 months.
5. Study participation decided to be contraindicated by the person in charge.
6. Administration of atazanavir sulfate and rilpivirin hydrochloride.
7. Severe allergy to or history of complications on using vonoprazan
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mariko Umezawa |
Organization
Nippon Medical School Hospital
Division name
Department of Gastroenterology
Zip code
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo 113-8603
TEL
03-3822-2131
m-umezawa@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mariko Umezawa |
Organization
Nippon Medical School Hospital
Division name
Department of Gastroenterology
Zip code
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo 113-8603
TEL
03-3822-2131
Homepage URL
m-umezawa@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
| 2017 | Year | 05 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | 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
| 2017 | Year | 04 | Month | 18 | Day |
Last modified on
| 2017 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030992
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
