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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000853
Receipt No. R000001024
Scientific Title Randomized control trial of Rabeprazole for prevention of aspirin-associated ulcers
Date of disclosure of the study information 2008/01/01
Last modified on 2008/09/22

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Basic information
Public title Randomized control trial of Rabeprazole for prevention of aspirin-associated ulcers
Acronym Randomized control trial of Rabeprazole for prevention of aspirin-associated ulcers
Scientific Title Randomized control trial of Rabeprazole for prevention of aspirin-associated ulcers
Scientific Title:Acronym Randomized control trial of Rabeprazole for prevention of aspirin-associated ulcers
Region
Japan

Condition
Condition Aspirin-associated ulcers
Classification by specialty
Medicine in general Gastroenterology Cardiology
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of rabeprazole for prevention of aspirin associated gastroduodenal ulcers
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Incidence of gastroduodenal ulcers
Key secondary outcomes gastroduodenal mucosal damage assessed by modified Lanza's score
hemorrhagic gastroduodenal ulcer
symptoms asssessed by Gastrointestinal Symptoms Rating Scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
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 Prevention
Type of intervention
Medicine
Interventions/Control_1 Rabeprazole
3 months
10mg/day
once per day
Interventions/Control_2 no treatment
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 is going to be introduced low-dose aspirin for more than four months
Key exclusion criteria History of peptic ulcer diseases
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiji Ogura
Organization University of Tokyo
Division name Clinical Research Center
Zip code
Address 7-3-1 Hongo, Bunkyo-ku Tokyo
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keiji Ogura
Organization University of Tokyo
Division name Clinical Research Center
Zip code
Address
TEL
Homepage URL
Email keiji-tky@umin.ac.jp

Sponsor
Institute University of Tokyo, Department of Gastroenterology
Institute
Department

Funding Source
Organization Department of Gastroenterology
University of Tokyo
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
2008 Year 01 Month 01 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
Date of protocol fixation
2007 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2009 Year 12 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
2007 Year 10 Month 16 Day
Last modified on
2008 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001024

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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