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
Information provided by:
Nagoya University Identifier:
First received: March 2, 2009
Last updated: September 18, 2009
Last verified: September 2009
The purpose of this study is to evaluate the long-term clinical significance of small-intestinal mucosal injuries in chronic NSAIDs-users.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Nagoya University:

Estimated Enrollment: 100
Study Start Date: October 2009

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Naoki Ohmiya, Department of Gastroenterology, Nagoya University Hospital Identifier: NCT00854490     History of Changes
Other Study ID Numbers: NO-002 
Study First Received: March 2, 2009
Last Updated: September 18, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 24, 2016