Follow-up Study of Small-intestinal Mucosal Injuries in Chronic Non-steroidal Anti-inflammatory Drugs (NSAIDs)-Users

Tokai National Higher Education and Research System

Status: Unknown

Conditions: Enteropathy

Study type: Observational

Funder types: Other

Identifiers

NCT00854490

NO-002

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term clinical significance of small-intestinal mucosal injuries in chronic NSAIDs-users.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• written informed consent
• 20 to 85 years of age
• RA, OA, or low back pain
• taking oral diclofenac sodium over 3 months
• No change of drugs before 3 months
• under 5 mg of corticosteroid use
• CRP < 1mg/dl

Exclusion criteria

• known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
• prostaglandins, metronidazole or salazosulfapyridine
• can not swallow
• with pacemaker
• after gastrointestinal operation
• serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease.
• any other conditions that the investigator feels would interfere with data interpretation or create under risk