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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Nagoya University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Nagoya University
ClinicalTrials.gov Identifier:
NCT00854490
First received: March 2, 2009
Last updated: September 18, 2009
Last verified: September 2009

March 2, 2009
September 18, 2009
October 2009
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Complete list of historical versions of study NCT00854490 on ClinicalTrials.gov Archive Site
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Follow-up Study of Small-intestinal Mucosal Injuries in Chronic Non-steroidal Anti-inflammatory Drugs (NSAIDs)-Users
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The purpose of this study is to evaluate the long-term clinical significance of small-intestinal mucosal injuries in chronic NSAIDs-users.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Chronic NSAID users

Enteropathy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
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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
Both
20 Years to 80 Years
No
Contact: Naoki Ohmiya, MD., Ph.D. 81-52-744-2172 nohmiya@med.nagoya-u.ac.jp
Japan
 
NCT00854490
NO-002
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Naoki Ohmiya, Department of Gastroenterology, Nagoya University Hospital
Nagoya University
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Nagoya University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP