UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001375 |
|---|---|
| Receipt number | 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 20:06:34 |
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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
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
Sponsor or person
Institute
Endoscopy Center, Tokyo Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001670
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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