Follow-up Study of Small-Intestinal Mucosal Injuries in Chronic Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)-Users

This study is not yet open for participant recruitment.

Verified by Nagoya University, March 2009

First Received: March 2, 2009 No Changes Posted

Sponsored by:	Nagoya University
Information provided by:	Nagoya University
ClinicalTrials.gov Identifier:	NCT00854490

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by Nagoya University:

Estimated Enrollment:	100
Study Start Date:	April 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, Aichi Prefecture
Nagoya University Hospital
Nagoya City, Aichi Prefecture, Japan, 466-8550

Sponsors and Collaborators

Nagoya University

More Information

No publications provided

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Digestive System Diseases
Analgesics, Non-Narcotic
Gastrointestinal Diseases
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Intestinal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Intestinal Diseases
Pharmacologic Actions
Digestive System Diseases
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 06, 2009