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

September 18, 2009 updated by: Nagoya University
The purpose of this study is to evaluate the long-term clinical significance of small-intestinal mucosal injuries in chronic NSAIDs-users.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi Prefecture
      • Nagoya City, Aichi Prefecture, Japan, 466-8550

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic NSAID users

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagoya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Study Registration Dates

First Submitted

March 2, 2009

First Submitted That Met QC Criteria

March 2, 2009

First Posted (Estimate)

March 3, 2009

Study Record Updates

Last Update Posted (Estimate)

September 21, 2009

Last Update Submitted That Met QC Criteria

September 18, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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