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
  Purpose

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


Condition
Enteropathy

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
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Naoki Ohmiya, Department of Gastroenterology, Nagoya University Hospital
ClinicalTrials.gov 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:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 20, 2014