UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007978 |
|---|---|
| Receipt number | R000009391 |
| Scientific Title | Evaluation of low-dose aspirin and non-steroidal anti-inflammatory drugs-induced small intestinal injury by video capsule endoscopy |
| Date of disclosure of the study information | 2012/05/17 |
| Last modified on | 2012/05/17 18:24:25 |
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Basic information
Public title
Evaluation of low-dose aspirin and non-steroidal anti-inflammatory drugs-induced small intestinal injury by video capsule endoscopy
Acronym
Evaluation of low-dose aspirin and non-steroidal anti-inflammatory drugs-induced small intestinal injury by video capsule endoscopy
Scientific Title
Evaluation of low-dose aspirin and non-steroidal anti-inflammatory drugs-induced small intestinal injury by video capsule endoscopy
Scientific Title:Acronym
Evaluation of low-dose aspirin and non-steroidal anti-inflammatory drugs-induced small intestinal injury by video capsule endoscopy
Region
| Japan |
Condition
Condition
low-dose aspirin and non-steroidal anti-inflammatory drugs induced small intestinal injury
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Orthopedics | Neurosurgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of pathophysiology of low-dose aspirin and non-steroidal anti-inflammatory drugs induced small intestinal injury
Basic objectives2
Others
Basic objectives -Others
Elucidation of pathophysiology of low-dose aspirin and non-steroidal anti-inflammatory drugs induced small intestinal injury
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurence frequency and characteristics of low-dose aspirin and non-steroidal anti-inflammatory drugs induced small intestinal injury
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The subject who agree to participate in the study by written informed consent.
4) The subjects from age 20 years old.
Key exclusion criteria
1) Subjects with the diseases which induce small intestinal injury such as Chrohn's disease, gastrointestinal stromal tumor, small intestinal tumor.
2) The subject taking drugs which have potential to induce small intestinal injury such as NSAIDs, anticancer drugs.
5) The subjects having diverticula and diaphragm-like stenosis in the small intestine.
6) The subject who have renal and hepatic disfunction.
9) The subjects who are judged to be inappropriate for this study by doctors conducting the study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya tanigawa |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka City
TEL
0666453811
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Tanigawa |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka City
TEL
0666453811
Homepage URL
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2012 | Year | 05 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Video capsule endoscopy revealed that low-dose aspirin and NSAIDs induce small intestinal injury.
Management information
Registered date
| 2012 | Year | 05 | Month | 17 | Day |
Last modified on
| 2012 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009391
