A double-blind, randomized, placebo controlled trial of misoprostol for healing of small bowel ulcers in aspirin users with small bowel bleeding
- Conditions
- small bowel ulcers in aspirin users with small bowel bleeding
- Registration Number
- JPRN-UMIN000011076
- Lead Sponsor
- Osaka City University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 82
Not provided
1. increased risk of capsule retention (e.g. gastric outlet obstruction, bypass surgery, Crohn's disease or suspected small bowel stricture) 2.abnormal findings on upper endoscopy (e.g. esophageal varices, grade C or D erosive esophagitis, vascular malformations, ulcer more than five erosions, neoplasms) or colonoscopy (e.g. cancer, polyps >1 cm, inflammatory bowel disease, vascular malformations, bleeding hemorrhoids or diverticular disease) 3.unable to swallow the video capsule 4.terminal illness 5.concomitant use of NSAIDs, sucralfate, rebamepide, anticoagulants, corticosteroids (prednisolone >7.5 mg daily or equivalent), and iron supplement 6.pregnancy or women of child-bearing age without regular use of contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete healing of small bowel ulcers (scores 3 or 4) in 8 weeks.
- Secondary Outcome Measures
Name Time Method