UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030393 |
|---|---|
| Receipt number | R000034701 |
| Scientific Title | Multicenter randomized crossover study about Every Second Day administration of Vonoprazan for the maintenance treatment of erosive GERD |
| Date of disclosure of the study information | 2017/12/14 |
| Last modified on | 2018/12/30 15:42:15 |
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Basic information
Public title
Multicenter randomized crossover study about Every Second Day administration of Vonoprazan for the maintenance treatment of erosive GERD
Acronym
ESD-Von-GERD
Scientific Title
Multicenter randomized crossover study about Every Second Day administration of Vonoprazan for the maintenance treatment of erosive GERD
Scientific Title:Acronym
ESD-Von-GERD
Region
| Japan |
Condition
Condition
erosive GERD
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of P-CAB every other day administration as GERD maintenance therapy by crossover with PPI every other day administration
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
proportion of asymptomatic patients. We defined an asymptomatic patient as a patient being free of symptoms according to the symptom diary records for 6 or more days per week
Key secondary outcomes
suppressive effect of GERD symptoms, proportion of asymptomatic patients at each time point, safety and cost saving effect of P-CAB every other day administration, compliance with every other day administration, proportion of asymptomatic patients at the first month of study drug administration
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Every Other Day Administration of Vonoprazan
Interventions/Control_2
Every Other Day Administration of Lansoprazole
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
erosive GERD patients who receive maintenance therapy with PPI
Key exclusion criteria
1) Receiving P-CAB administration
2) For those PPI maintenance therapy is ineffective
3) Having undergone gastroesophageal surgery
4) In very bad compliance
5) Allergic to PPI or Vonoprazan
6) With serious complications
7) Pregnant, breastfeeding, or possibly pregnant
8) Deemed inappropriate for participation in this study by the principal investigator/sub-investigators
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
National Hospital Organization Hakodate National Hospital
Division name
Direcor
Zip code
Address
18-16, Kawaharachou, Hakodate
TEL
0138-51-6281
mkato1957@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamiko Demura |
Organization
National Hospital Organization Hakodate National Hospital
Division name
Clinical Research Center
Zip code
Address
18-16, Kawaharachou, Hakodate
TEL
0138-51-6281
Homepage URL
rinshouk@hnh.hosp.go.jp
Sponsor or person
Institute
Department of Gastroenterology, National Hospital Organization Hakodate National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
国立病院機構 金沢医療センター
国立病院機構 東京医療センター
国立病院機構 大阪医療センター
国立病院機構 呉医療センター
国立病院機構 岡山医療センター
国立病院機構 九州医療センター
国立病院機構 大阪南医療センター
国立病院機構 東広島医療センター
国立病院機構 高知病院
国立病院機構 三重中央医療センター
国立病院機構 京都医療センター
国立病院機構 北海道医療センター
国立病院機構 仙台医療センター
国立病院機構 福岡東医療センター
国立病院機構 災害医療センター
国立病院機構 福山医療センター
国立病院機構 函館病院
国立病院機構 まつもと医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 14 | Day |
Last modified on
| 2018 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034701
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
