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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001695
Receipt No. R000001931
Scientific Title Evaluation of changes in gastrointestinal lesions following low dose aspirin administration
Date of disclosure of the study information 2009/02/09
Last modified on 2012/02/09

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Basic information
Public title Evaluation of changes in gastrointestinal lesions following low dose aspirin administration
Acronym Gastrointestinal lesions after low dose aspirin
Scientific Title Evaluation of changes in gastrointestinal lesions following low dose aspirin administration
Scientific Title:Acronym Gastrointestinal lesions after low dose aspirin
Region
Japan

Condition
Condition gastroduodenal ulcer, intestinal ulcer
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To see whether low dose aspirin administration induces new gastrointestinal lesions
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Endoscopic gastrointestinal mucosal lesions before and 1m after initiation of low dose aspirin administration
Key secondary outcomes Endoscopic gastrointestinal mucosal lesions 1y after initiation of low dose aspirin administration

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria those who start taking low dose aspirin
Key exclusion criteria those who have taken aspirin within the last 2 months
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Matsuhashi
Organization Kanto Medical Center, NTT East
Division name Department of Gastroenterology
Zip code
Address 5-9-22 Higashi-gotanda, Shinagawa-ku, Tokyo
TEL 03-3448-6245
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Matsuhashi
Organization Kanto Medical Center, NTT East
Division name Department of Gastroenterology
Zip code
Address 5-9-22 Higashi-gotanda, Shinagawa-ku, Tokyo
TEL 03-3448-6245
Homepage URL
Email nmatuha-tky@umin.ac.jp

Sponsor
Institute Kanto Medical Center, NTT EastKanto Medical Center, NTT East
Institute
Department

Funding Source
Organization Kanto Medical Center, NTT East
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 09 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 Completed
Date of protocol fixation
2009 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2009 Year 02 Month 09 Day
Last modified on
2012 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001931

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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