UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008519 |
|---|---|
| Receipt number | R000010012 |
| Scientific Title | Assessment of the risk factors for the presence of low-dose aspirin-induced small bowel injury |
| Date of disclosure of the study information | 2012/07/25 |
| Last modified on | 2012/07/24 14:41:30 |
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Basic information
Public title
Assessment of the risk factors for the presence of low-dose aspirin-induced small bowel injury
Acronym
Assessment of the risk factors for the presence of low-dose aspirin-induced small bowel injury
Scientific Title
Assessment of the risk factors for the presence of low-dose aspirin-induced small bowel injury
Scientific Title:Acronym
Assessment of the risk factors for the presence of low-dose aspirin-induced small bowel injury
Region
| Japan |
Condition
Condition
small bowel mucosal injury
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the risk factors (including demographic and behavioral characteristics, comorbidity and medication use) for the presence of small bowel mucosal injury in low-dose aspirin users
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency and numbers of low-dose aspirin-induced small bowel erosions and ulcerations evaluated by capsule endoscopy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with LDA use more than three months prior this study.
2. Willingness to provide written informed consent.
Key exclusion criteria
1. History of NSAIDs use within three months prior this study
2. History of inflammatory bowel disease
3. History of severe renal failure and/or hepatic failure
4. Patients with implantable pacemaker
5. Patients with dysphagia.
6. Patients who have history of the ileus or stricture or fistula of the intestine.
7. Patients who can not give informed consent for operation to retrieve the capsule.
8. The patients who have severe heart failure and respiratory failure.
9. Patients judged as inappropriate candidates for the trial by the investigators
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Endo |
Organization
Yokohama City University
Division name
Division of Endoscopy
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University
Division name
Division of Endoscopy
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
Homepage URL
Sponsor or person
Institute
Division of Endoscopy, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
横浜市立大学病院、茅ヶ崎市立病院、平塚市民病院、小田原市立病院、横浜労災病院、町田市民病院、都立広尾病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 25 | 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
| 2012 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Capsule endoscopic findings
Management information
Registered date
| 2012 | Year | 07 | Month | 24 | Day |
Last modified on
| 2012 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010012
