UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To prevent low-dose aspirin induced peptic ulcers, which is better the use of proton pump inhibitors or histamine type2 receptor agonist; randomized controlled trial
Title of the study (Brief title)	To prevent low-dose aspirin induced peptic ulcers, which is better the use of PPI or H2RA
Region	Japan

Condition
Condition	the patients who are taking low dose aspirin
Classification by specialty	Gastroenterology Cardiology Neurology Neurosurgery Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is said that to prevent low-dose aspirin induced peptic ulcers, proton pump inhibitors (PPI) is effective. In Western contries, it is said that taking histamine-2 receptor antagonists (H2RA) is effective to prevent those ulcers. It is necessary to prove that conclusion is truth or not in Japan.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	with or without peptic ulcer on the patients who are taking low dose aspirin
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	famotidine 40mg/day
Interventions/Control_2	lansoprazole 15mg/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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient who fills everything the following 1)Patients who are taking low-dose aspirin 2) Patient of 20 years or older and 90 years or younger 3) Patient who gives written informed consent
Key exclusion criteria	The patient who collides with either the following assumes that it doesn't put it in to the examination 1) Drug allergy 2)Patient who have taken PPI 3)Patient who have taken clopidogrel, antifungal agent, and corticosteroid 4)Patient who have malignant neoplasm 5)Patient who is postgastrectomy 6)pregnant and lactation 7)Liver disorder, renal disorder, bronchial asthma
Target sample size	400

Research contact person
Name of lead principal investigator	Atsushi Nakajima
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Address	3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
Email

Public contact
Name of contact person	Masahiko Inamori
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Address	3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 09 Month 04 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 08 Month 17 Day
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date	2014 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 08 Month 25 Day
Last modified on	2017 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002927