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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002941
Receipt No. R000003577
Scientific Title The analysis of QOL in the patients of GERD with chronic liver disease after the treatment of PPI or H2-B
Date of disclosure of the study information 2009/12/25
Last modified on 2011/10/31

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Basic information
Public title The analysis of QOL in the patients of GERD with chronic liver disease after the treatment of PPI or H2-B
Acronym The analysis of QOL in the patients of GERD with chronic liver disease after the treatment of PPI or H2-B
Scientific Title The analysis of QOL in the patients of GERD with chronic liver disease after the treatment of PPI or H2-B
Scientific Title:Acronym The analysis of QOL in the patients of GERD with chronic liver disease after the treatment of PPI or H2-B
Region
Japan

Condition
Condition The patients of GERD with chronic liver disease
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The improvement of QOL with GERD and chronic liver disease after the treatment of PPI or H2-B
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The symptons of upper gastrointestine evaluated by F-sacle
Key secondary outcomes The symptons by SF-8
gastrointesitinal peptide

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sodium rabeprazole
Interventions/Control_2 ranitidine hydrochloride
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients evaluated by F-scale
The patients evaluated by SF-8
The patients without gastric ulcer or duodenal ulcer
The patients with chronic liver disease
Key exclusion criteria The patients with allergy for sodium rabeprazole and ranitidine hydrochloride
The patients with severe live failure
The patients treated by Interferon or with malignant tumor
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MAKOTO ARAI
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba City
TEL 043-226-2083
Email

Public contact
Name of contact person
1st name
Middle name
Last name MAKOTO ARAI
Organization CHiba University Hospital
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute CHiba University hospital
Institute
Department

Funding Source
Organization Chiba University hospital
Organization
Division
Category of Funding Organization Other
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 千葉大学病院

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 25 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 Completed
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 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
2009 Year 12 Month 25 Day
Last modified on
2011 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003577

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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