UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002941 |
|---|---|
| Receipt number | 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 09:52:36 |
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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
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
Sponsor or person
Institute
CHiba University hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003577
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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