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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002382
Receipt No. R000002927
Scientific Title 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
Date of disclosure of the study information 2009/09/04
Last modified on 2017/07/29

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Basic information
Public title 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
Acronym To prevent low-dose aspirin induced peptic ulcers, which is better the use of PPI or H2RA
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Atsushi Nakajima
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Inamori
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
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)

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 09 Month 04 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
2009 Year 08 Month 17 Day
Date of IRB
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

Other
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

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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