Effects of rebamipide on nonsteroidal anti-inflammatory drugs-induced small bowel injury

UMIN ID: UMIN000000658

Registered date:29/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Small bowel injuries
• Date of first enrollment: 2007/03/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients in the treatment group receive rebamipide 300 mg/day for 8 weeks.
Patients in the control group do not receive rebamipide.

Outcome(s)

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

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