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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000761
Receipt No. R000000912
Scientific Title Study of prevention in aspirin ulcer of the gastro-duodenum
Date of disclosure of the study information 2009/08/01
Last modified on 2007/07/03

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Basic information
Public title Study of prevention in aspirin ulcer of the gastro-duodenum
Acronym Prevention study of aspirin ulcer
Scientific Title Study of prevention in aspirin ulcer of the gastro-duodenum
Scientific Title:Acronym Prevention study of aspirin ulcer
Region
Japan

Condition
Condition patients taking aspirin
Classification by specialty
Gastroenterology Cardiology Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate that proton pump inhibitor (PPI) is superior to histamin antagonist (H2 blocker) for prevention of gastro-duodenal ulcer in Japanese patients taking aspirin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes presence of gastro-duodenal erosion or ulcer in endoscopic examination
Key secondary outcomes estimation of Hericobactor pyroli

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 considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1 year lansoplazole:15mg/day
Interventions/Control_2 1 year famotidine:40mg/day
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
85 years-old >=
Gender Male and Female
Key inclusion criteria patients taking low-dose aspirin, age range (20-85 year-old)
Key exclusion criteria Patients were excluded the following criteria: inadequate organ functions, pregnancy, uncontrolable DM, malignancy, state after gastrectomy, and receiving stereid or warfarin.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Kaneko
Organization Showa University School of Medicine
Division name Second Department of Internal Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL 03-3784-8535
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Konishi
Organization Showa University School of MedicineShowa University School of Medicine
Division name Second Department of Internal Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL 03-3784-8535
Homepage URL http://www.showa-u.ac.jp
Email konishigi66@aol.com

Sponsor
Institute Second Department of Internal Medicine, Showa University School of Medicine
Institute
Department

Funding Source
Organization Non profit foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 08 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
2005 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 11 Month 01 Day
Last follow-up date
2010 Year 07 Month 01 Day
Date of closure to data entry
2010 Year 07 Month 01 Day
Date trial data considered complete
2010 Year 07 Month 01 Day
Date analysis concluded
2010 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 07 Month 03 Day
Last modified on
2007 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000912

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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