UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001264 |
|---|---|
| Receipt number | R000001539 |
| Scientific Title | Clinical trial on the incidence of small bowel injury induced by low-dose aspirin: a crossover study using capsule endoscopy in healthy volunteers |
| Date of disclosure of the study information | 2008/07/24 |
| Last modified on | 2008/12/01 18:50:59 |
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Basic information
Public title
Clinical trial on the incidence of small bowel injury induced by low-dose aspirin: a crossover study using capsule endoscopy in healthy volunteers
Acronym
Incidence of small bowel injury induced by low-dose aspirin
Scientific Title
Clinical trial on the incidence of small bowel injury induced by low-dose aspirin: a crossover study using capsule endoscopy in healthy volunteers
Scientific Title:Acronym
Incidence of small bowel injury induced by low-dose aspirin
Region
| Japan |
Condition
Condition
Small bowel mucosal injury
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of small bowel injury in healthy volunteers treated with short-term low-dose aspirin using capsule endoscopy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of capsule endoscopic findings (red spots, loss of villi, mucosal breaks)
Key secondary outcomes
Symptom assessment (abdominal pain, diarrhea, melena)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Enteric-coated aspirin 100 mg/day for 14 days - (washout period of at least 4 weeks) - no drug for 14 days
Interventions/Control_2
No drug for 14 days - (washout period of at least 4 weeks) - enteric-coated aspirin 100 mg/day for 14 days
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
| Not applicable |
Gender
Male
Key inclusion criteria
a. Healthy male subjects who have a normal physical examination and laboratory results
b. Obtaining informed consent
Key exclusion criteria
a. Subjects taken NSAID or aspirin within the last 3 months
b. Allergic or idiosyncratic to the drug
c. Useage of antiulcer medication (H2RA, PPI or misoprostol)
d. Chronic alcohol consumption
e. A history of abdominal surgery
f. Serious central nervous system
g. Psychiatric diseases
h. Cardiovascular diseases
i. Respiratory diseases
j. Gastrointestinal diseases
k. The subject of any other clinical test/trial which will affect the results this study
l. Can not comply with the study requirements or cannot follow instructions for the device
m. Do not agree to remove the capsule either by endoscopically or surgically when retention occurred
o. Inadequate to entry judged by investigators
Target sample size
20
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 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
Homepage URL
Sponsor or person
Institute
Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
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 | 07 | Month | 24 | 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
| 2008 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 07 | Month | 23 | Day |
Last modified on
| 2008 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001539
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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