UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000663 |
|---|---|
| Receipt number | R000000799 |
| Scientific Title | Clinical study on the incidence of small bowel injury by low-dose aspirin, and efficacy of misoprostol for the treatment of aspirin-induced small bowel injury |
| Date of disclosure of the study information | 2007/03/30 |
| Last modified on | 2011/03/31 16:12:12 |
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Basic information
Public title
Clinical study on the incidence of small bowel injury by low-dose aspirin, and efficacy of misoprostol for the treatment of aspirin-induced small bowel injury
Acronym
Incidence of small bowel injury by low-dose aspirin, and efficacy of misoprostol for the treatment of small bowel injury
Scientific Title
Clinical study on the incidence of small bowel injury by low-dose aspirin, and efficacy of misoprostol for the treatment of aspirin-induced small bowel injury
Scientific Title:Acronym
Incidence of small bowel injury by low-dose aspirin, and efficacy of misoprostol for the treatment of small bowel injury
Region
| Japan |
Condition
Condition
Small bowel injury
Classification by specialty
| Gastroenterology | Cardiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of small bowel injuriy in chronic users of low-dose aspirin and efficacy of misoprostol for the treatment of aspirin-induced small bowel injury by capsule endoscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Capsule endoscopic findings (number of ulcers/erosions and red spots)
Key secondary outcomes
Symptom assessment (anemia, melena, diarrhea, abdominal pain)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Misoprostol (800 microgram/day) for 8 weeks
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
Chronic users of low-dose aspirin with a peptic ulcer who receive therapy with a proton pump inhibitor
Key exclusion criteria
1. Dysphagia.
2. Pregnant, possibly pregnant, or lactating women.
3. With intestinal stricture or intestinal fistula, diagnosed by diagnostic image or past clinical inspection.
4. Using cardiac pacemaker or other self-contained medical electronics.
5. The subject of any other clinical test/trial which will affect the results this study.
6. Can not comply with the study requirements or cannot follow instructions for the device.
7. Extensive esophageal hiatal hernia.
8. Life-threatening disorder.
9. Abdominal radiotherapy in past.
10. Do not agree to remove the capsule either by endoscopically or surgically when retention occurred.
11. Allergic or idiosyncratic to the drug.
12. Inadequate to entry judged by investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Watanabe |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
watanabet@med.osaka-cu.ac.jp
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
| 2007 | Year | 03 | Month | 30 | 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
| 2006 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 10 | 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
| 2007 | Year | 03 | Month | 30 | Day |
Last modified on
| 2011 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000799
