Small intestinal mucosal adaptation in the long-term administration of a NSAID and the efficacy of irsogladine maleate, a gastroprotective drug, and omeprazole in healthy volunteers: a prospective randomized trial
Phase 4
- Conditions
- SAID induced small intestinal lesions
- Registration Number
- JPRN-UMIN000007540
- Lead Sponsor
- Second Department of Internal Medicine, Osaka Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of small intestinal mucosal breaks evaluated in the capsule endoscope.
- Secondary Outcome Measures
Name Time Method 1. fecal calprotectin 2. hemoglobin 3. occult fecal blood test