Clinical trial on the incidence of small bowel injury induced by low-dose aspirin: a crossover study using capsule endoscopy in healthy volunteers
Not Applicable
- Conditions
- Small bowel mucosal injury
- Registration Number
- JPRN-UMIN000001264
- Lead Sponsor
- Gastroenterology Division, Yokohama City University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of capsule endoscopic findings (red spots, loss of villi, mucosal breaks)
- Secondary Outcome Measures
Name Time Method Symptom assessment (abdominal pain, diarrhea, melena)