Status:

UNKNOWN

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

Lead Sponsor:

Nagoya University

Conditions:

Enteropathy

Eligibility:

All Genders

20-80 years

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00854490

Start Date

October 1 2009

Last Update

September 21 2009

Active Locations (1)

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1

Nagoya University Hospital

Nagoya, Aichi-ken, Japan, 466-8550