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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001375
Receipt No. R000001670
Scientific Title Clinical trial on the incidence of upper gastrointestinal mucosal injury induced by low-dose aspirin: a randamized control study using transnasal endoscopy in healthy volunteers
Date of disclosure of the study information 2008/09/14
Last modified on 2013/04/14

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Basic information
Public title Clinical trial on the incidence of upper gastrointestinal mucosal injury induced by low-dose aspirin: a randamized control study using transnasal endoscopy in healthy volunteers
Acronym Incidence of upper gastrointestinal mucosal injury induced by low-dose aspirin
Scientific Title Clinical trial on the incidence of upper gastrointestinal mucosal injury induced by low-dose aspirin: a randamized control study using transnasal endoscopy in healthy volunteers
Scientific Title:Acronym Incidence of upper gastrointestinal mucosal injury induced by low-dose aspirin
Region
Japan

Condition
Condition upper gastrointestinal mucosal injury
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the incidence of upper gastrointestinal injury in healthy volunteers treated with short-term low-dose aspirin using transnasal endoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The number of transnasal endoscopic findings (red spots, petechiae, erosion, ulcer)
Key secondary outcomes Symptom assessment (using GSRS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 three kinds of placeboes for 7 days
Interventions/Control_2 Enteric-coated aspirin 100 mg/day + two kinds of placeboes for 7 days
Interventions/Control_3 Enteric-coated aspirin 100 mg/day + rebamipide 300mg/day + placebo for 7 days
Interventions/Control_4 Enteric-coated aspirin 100 mg/day + omeprazole 20mg/day + placebo for 7 days
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 a. Healthy subjects who have a normal physical examination and laboratory results
b. Obtaining informed consent
c. H.pylori negative
Key exclusion criteria a. hemorrhage tendency
b. hypersensitivity for element of aspirin
c. previous history of aspirin induced asthma
d. previous history of peptic ulcer
e. severe blood disease
f. severe complication (malignant tumor, liver cirrhosis, renal failure, cardiac failure, etc)
g. pregnant woman,or possibility of pregnancy
h. smoker
i. Inadequate to entry judged by investigators
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kawai
Organization Tokyo Medical University Hospital
Division name Endoscopy Center
Zip code
Address 6-7-1, Nishishinjuku,Shinjuku-ku, Tokyo, Japan
TEL 03-3342-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kawai
Organization Tokyo Medical University Hospital
Division name Endoscopy Center
Zip code
Address 6-7-1, Nishishinjuku,Shinjuku-ku, Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute Endoscopy Center, Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization Endoscopy Center, Tokyo Medical University Hospital
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
2008 Year 09 Month 14 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 No longer recruiting
Date of protocol fixation
2008 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2009 Year 03 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
2008 Year 09 Month 14 Day
Last modified on
2013 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001670

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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