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

NCT ID: NCT00854490

Last Updated: 2009-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Enteropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nagoya University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Gastroenterology, Nagoya University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Naoki Ohmiya, MD., Ph.D.

Role: CONTACT

81-52-744-2172

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Naoki Ohmiya, M.D., Ph.D>

Role: primary

81-52-744-2172

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NO-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.