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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001679
Receipt No. R000002027
Scientific Title Effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury
Date of disclosure of the study information 2009/02/02
Last modified on 2014/08/03

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Basic information
Public title Effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury
Acronym Effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury
Scientific Title Effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury
Scientific Title:Acronym Effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury
Region
Japan

Condition
Condition Patients having taken low-dose aspirin
Classification by specialty
Gastroenterology Cardiology Endocrinology and Metabolism
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the improvement of gastroduodenal mucosal injury in patients having taken low-dose aspirin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of endoscopic finding before and 4 weeks after initiating rabeprazole or sucralfate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 rabeprazole 10mg/day, 4 weeks
Interventions/Control_2 sucralfate 3g/day, 4 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have taken low-dose aspirin regularly
Key exclusion criteria 1.below 20 years of age
2.contraindication against rabeprazole and sucralfate
3.malignancy
4.pregnancy
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Kuyama
Organization Teikyo University School of Medicine
Division name Internal Medicine
Zip code
Address 2-11-1 Kaga Itabashi-ku Tokyo
TEL 03-3964-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Teikyo University School of Medicine
Division name Internal Medicine
Zip code
Address
TEL
Homepage URL
Email ymmt@med.teikyo-u.ac.jp

Sponsor
Institute Department of Internal Medicine, Teikyo University School of Medicine
Institute
Department

Funding Source
Organization Teikyo University School of 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
2009 Year 02 Month 02 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 Terminated
Date of protocol fixation
2008 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 01 Day
Last modified on
2014 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002027

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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