UMIN-CTR Clinical Trial

Basic information
Public title	Preventive effect of rabeprazole and sucralfate on gastroduodenal mucosal injury in patients taking low-dose aspirin
Acronym	Preventive effect of rabeprazole and sucralfate on gastroduodenal mucosal injury in patients taking low-dose aspirin
Scientific Title	Preventive effect of rabeprazole and sucralfate on gastroduodenal mucosal injury in patients taking low-dose aspirin
Scientific Title:Acronym	Preventive effect of rabeprazole and sucralfate on gastroduodenal mucosal injury in patients taking low-dose aspirin
Region	Japan

Condition
Condition	Patients who have plan to receive 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 preventive effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of endoscopic finding before and 4 weeks after initiating low-dose aspirin (Comparison between rabeprazole and 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	Prevention
Type of intervention	Medicine
Interventions/Control_1	rabeprazole: 10mg/day, 4 week given with aspirin 100mg/day
Interventions/Control_2	scralfate 3g/day, 4 week given with aspirin 100mg/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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have a plan to receive low-dose aspirin
Key exclusion criteria	1.taking low-dose aspirin 2.below 20 years of age 3.contraindication against rabeprazole and sucralfate 4.malignancy 5.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 Itabashiku 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=R000002026

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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