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

• Conditions: Enteropathy

• Registration Number: NCT00854490
• Lead Sponsor: Nagoya University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Study First Posted: 2009-03-03
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-18
• Last Update Posted: 2009-09-21
• Study Start: 2009-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Nagoya University Hospital; 🇯🇵 Nagoya City, Aichi Prefecture, Japan