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

UMIN ID: UMIN000000663

Registered date:30/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Small bowel injury
• Date of first enrollment: 2007/03/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Misoprostol (800 microgram/day) for 8 weeks

Outcome(s)

• Primary Outcome: Capsule endoscopic findings (number of ulcers/erosions and red spots)
• Secondary Outcome: Symptom assessment (anemia, melena, diarrhea, abdominal pain)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Osaka City University Graduate School of Medicine
• Source(s) of Monetary Support: Osaka City University Graduate School of Medicine