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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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ClinicalTrials.gov Identifier: NCT00854490
Recruitment Status : Unknown
Verified September 2009 by Nagoya University.
Recruitment status was:  Not yet recruiting
First Posted : March 3, 2009
Last Update Posted : September 21, 2009
Sponsor:
Information provided by:

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

Condition or disease
Enteropathy

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2009
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic NSAID users
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854490


Contacts
Contact: Naoki Ohmiya, MD., Ph.D. 81-52-744-2172 nohmiya@med.nagoya-u.ac.jp

Locations
Japan
Nagoya University Hospital Not yet recruiting
Nagoya City, Aichi Prefecture, Japan, 466-8550
Contact: Naoki Ohmiya, M.D., Ph.D>    81-52-744-2172    nohmiya@med.nagoya-u.ac.jp   
Sponsors and Collaborators
Nagoya University
More Information

Responsible Party: Naoki Ohmiya, Department of Gastroenterology, Nagoya University Hospital
ClinicalTrials.gov Identifier: NCT00854490     History of Changes
Other Study ID Numbers: NO-002
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents