NSAID induced Alimentary Tract Lesions
Conditions
Interventions
irsogladine 4mg/day and dicrofenacNa 75mg/day for 2 weeks in oral administration
omeprazole 10mg/day and dicrofenacNa75mg/day for 2 weeks in oral administration
Sponsors
Second Department of Internal Medicine, Osaka Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adults who are 20 years or older, and less than 80 years of age at the time of obtaining consent 2) Subjects from whom fully informed written consent based on their full understanding and their own voluntary will was obtained when participating this study 3)Subjects who had taken no medication during the 1-month period before the start of this study
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of peptic ulcer or gastrointestinal bleeding 2) Subjects with significant hepatic disease, renal disease, heart disease, or respiratory disease 3) Subjects with a history of gastrointestinal surgery other than appendectomy 4) Subjects orally taking or planning to orally take drug other than antiulcer drug or NSAIDs 5) Subjects with alcohol or chemical dependencies 6) Subjects with a history of intestinal obstruction, or person with suspected gastrointestinal obstruction on other tests 7)Subjects who cannot agree that surgery may be required if capsule endoscope retained in the body 8) Subjects whom otherwise the investigator determined ineligible as the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of small intestinal mucosal breaks evaluated in the capsule endoscope. | — |
Countries
Japan
Outcome results
None listed