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

T

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

Trial contacts and locations

1

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Central trial contact

Naoki Ohmiya, MD., Ph.D.

Data sourced from clinicaltrials.gov

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