Follow-up Study of Small-intestinal Mucosal Injuries in NCT00854490

Updated 06/21/2024

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number	NCT00854490
Other study ID #	NO-002
Secondary ID
Status	Not yet recruiting
Phase	N/A
First received	March 2, 2009
Last updated	September 18, 2009
Start date	October 2009

Study information
Verified date	September 2009
Source	Nagoya University
Contact	Naoki Ohmiya, MD., Ph.D.
Phone	81-52-744-2172
Email	nohmiya[@]med.nagoya-u.ac.jp
Is FDA regulated	No
Health authority	Japan: Ministry of Health, Labor and Welfare
Study type	Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status	Not yet recruiting
Enrollment	100
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	20 Years to 80 Years
Eligibility	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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Enteropathy

Locations
Country	Name	City	State
Japan	Nagoya University Hospital	Nagoya City	Aichi Prefecture

Sponsors *(1)*
Lead Sponsor	Collaborator
Nagoya University

Country where clinical trial is conducted

Japan,

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