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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022989
Receipt No. R000007606
Scientific Title Comparative study of once vs. twice daily regimen of double dose of rabeprazole in uncontrolled GERD patients taking usual dose of proton pump inhibitors.
Date of disclosure of the study information 2016/07/02
Last modified on 2017/01/04

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Basic information
Public title Comparative study of once vs. twice daily regimen of double dose of
rabeprazole in uncontrolled GERD patients taking usual dose of proton pump
inhibitors.
Acronym Once vs. twice daily regimen of double dose PPI in GERD
Scientific Title Comparative study of once vs. twice daily regimen of double dose of
rabeprazole in uncontrolled GERD patients taking usual dose of proton pump
inhibitors.
Scientific Title:Acronym Once vs. twice daily regimen of double dose PPI in GERD
Region
Japan

Condition
Condition Gastro-Esophageal Reflux Disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarify the effectiveness of once or twice daily regimen of double dose of rabeprazole in uncontrolled GERD patients taking usual dose of proton pump
inhibitors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of GERD symptoms,sleep disturbance and QOL
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Twice per day divided administration method
Interventions/Control_2 Once per day administration method
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
89 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who have received upper GI endoscopic examination during 4 weeks before the clinical trial starts
.Subjects who have not received two-fold dose administration of PPI during 4 weeks before the clinical trial starts
Subjects who give informed consent by written from themselves or family members
Key exclusion criteria Subjects who have any mental disorders
Subjects who have histories of allergy against laperazol
Subjects who have serious complications and problems to continue to perform this clinical trial
Subjects who are pregnant, possibly pregnant, or feeding her children
Subjects who cannot accept an upper GI endoscopic examination
Subjects who have two-fold dose of PPI during 4 weeks before the clinical trial starts
Subjects who are decided to be unacceptable for this clinical trial by their clinical physicians
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Mizuki
Organization Keiyu Hospital
Division name Internal medicine
Zip code
Address 3-7-3 Minatomirai,Nishi-ku,Yokohama
TEL 045-221-8181
Email a-mizuki@keiyu-hospital.com

Public contact
Name of contact person
1st name
Middle name
Last name Akira Mizuki
Organization Keiyu Hospital
Division name Internal medicine
Zip code
Address 3-7-3 Minatomirai,Nishi-ku,Yokohama
TEL 045-221-8181
Homepage URL
Email a-mizuki@keiyu-hospital.com

Sponsor
Institute Keiyu Hospital
Internal Medicine
Institute
Department

Funding Source
Organization Keiyu Hospital
Internal Medicine
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
2016 Year 07 Month 02 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
2011 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 10 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
2016 Year 07 Month 02 Day
Last modified on
2017 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007606

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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