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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 2, 2009

Last Updated Date

September 18, 2009

Start Date ^ICMJE

October 2009

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00854490 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Chronic NSAID users

Condition ^ICMJE

Enteropathy

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Naoki Ohmiya, MD., Ph.D.

81-52-744-2172

nohmiya@med.nagoya-u.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00854490

Other Study ID Numbers ^ICMJE

NO-002

Has Data Monitoring Committee

Not Provided

Responsible Party

Naoki Ohmiya, Department of Gastroenterology, Nagoya University Hospital

Study Sponsor ^ICMJE

Nagoya University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Nagoya University

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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