NSAID-induced small bowel mucosal injury
Conditions
Interventions
Subjects in NSAID group are administered celecoxib 200mg twice per day and placebo 20mg once per day for two weeks.
Subjects in NSAID plus PPI group are administered celecoxib 200mg twice per day and
Sponsors
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Fukuoka Sanno Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers obtained written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of peptic ulcers 2) Subjects treated by corticosteroid (>10mg/day 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 gastrointestinal stenosis 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 inappropriate for the participation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number and incidence of small bowel pathologies (ulcer, hemorrhage and mucosal break) under capsule endoscopy after 2 weeks medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal symptoms and laboratory data. | — |
Countries
Japan
Outcome results
None listed