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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
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.

Condition or disease

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

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

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

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 identifier (NCT number): NCT00854490

Contact: Naoki Ohmiya, MD., Ph.D. 81-52-744-2172

Nagoya University Hospital Not yet recruiting
Nagoya City, Aichi Prefecture, Japan, 466-8550
Contact: Naoki Ohmiya, M.D., Ph.D>    81-52-744-2172   
Sponsors and Collaborators
Nagoya University

Responsible Party: Naoki Ohmiya, Department of Gastroenterology, Nagoya University Hospital 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
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents