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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030393
Receipt No. 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

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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
Email 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
Email rinshouk@hnh.hosp.go.jp

Sponsor
Institute Department of Gastroenterology, National Hospital Organization Hakodate National Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034701

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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