Prospective, randomized, double-blind, controlled study for the incidence of small bowel mucosal injury caused by selective COX-2 inhibitor in healthy volunteers
Not Applicable
- Conditions
- Small bowel mucosal injury
- Registration Number
- JPRN-UMIN000003871
- Lead Sponsor
- Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Subjects with a history of peptic ulcers 2) Subjects treated by corticosteroid (>10mg of prednisolone) 3) Subjects treated continuously with NSAIDs 4) Subjects treated with aspirin 5) Subjects with a history of aspirin-induced asthma 6) Subjects allergic to sulufonamids 7) Subjects treated with anti-ulcer drugs (misoprostol, rebamipide, teprenone, etc) 8) Subjects with stenosis of gastrointestinal tract or severe adhesion 9) Subjects with malignancy, psychosis, severe hepatic, renal dysfunction, heart disease, or hematologic disease 10) Pregnant and nursing women 11) Subjects with other disorders who are judged as inappropriate for the participation of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number and incidence of small bowel pathologies (ulcer, hemorrhage and mucosal break) under capsule endoscopy after 2 weeks medication.
- Secondary Outcome Measures
Name Time Method Abdominal symptoms and laboratory data including anemia