small intestinal injury
Conditions
Interventions
Patients in the treatment group receive rebamipide (900 mg/day) for 8 weeks.
Patients in the control group receive placebo for 8 weeks.
Sponsors
Osaka City University Graduate School of Medicine Osaka Medical College Kyoto Prefectural University of Medicine Saga University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The subject who agree to participate in the study by written informed consent. 2) The subjects taking aspirin enteric-coated tablets (Bayaspirin 100 tablet) for more than three months and planning to continue it for more than eight weeks. 3) The subjects who have ischemic heart disease and cerebrovascular diaseases and they are stable. 4) The subjects from age 20 to 75 years old. 5) We do not ask you sexuality. 6) The subjects proven to have small intestinalmucosal injury by capsule endoscopy.
Exclusion criteria
Exclusion criteria: 1) Subjects with the diseases which induce small intestinal injury such as Chrohn's disease, gastrointestinal stromal tumor, small intestinal tumor. 2) The subject taking drugs which have potential to induce small intestinal injury such as NSAIDs, anticancer drugs. 3) The subject taking antibiotics, sulfasalazine, prostaglandin analog, corticosteroids, free radical depressant, elastase depressant, mucoprotective drugs and drugs which have potential to improve small intestinal injury. 4) The subject having evident small intestinal bleeding. 5) The subjects having diverticula and diaphragm-like stenosis in the small intestine. 6) The subject who have renal and hepatic disfunction. 7) The subjects who has allergic hypersensitivity against rebamipide. 8) The subject who participate in other clinical studies within 4 weeks. 9) The subjects who are judged to be inappropriate for this study by doctors conducting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Capsule endoscopic findings (number of ulcers/erosions) | — |
Secondary
| Measure | Time frame |
|---|---|
| Lewis Score Symptom assessment (anemia, melena, complications) Safety | — |
Countries
Japan
Contacts
Public ContactToshio Watanabe
Osaka City University Graduate School of Medicine Gastroenterology
Outcome results
None listed