NSAIDs-induced Small-intestinal Injuries
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.
Interventions
DRUGRebamipide
100mg tid, 4 or 8 weeks
Sponsors
Nagoya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * 20 to 85 years of age * RA, OA, or low back pain * No change of drugs before 3 months * Under 5 mg of corticosteroid use * CRP \< 1mg/dl * Small-intestinal mucosal injuries more than one * Hemoglobin level is below normal range
Exclusion criteria
* Known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis * Prostaglandins, metronidazole or salazosulfapyridine * Can not swallow * Eith pacemaker * After gastrointestinal operation * Serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease. * Taking rebamipide before one week * Any other conditions that the investigator feels would interfere with data interpretation or create under risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of mucosal breaks | 4 and 8 weeks after treatment |
Countries
Japan
Contacts
Primary ContactNaoki Ohmiya, MD., Ph.D.
Outcome results
None listed