NCT00854490

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
Last Updated

September 21, 2009

Status Verified

September 1, 2009

First QC Date

March 2, 2009

Last Update Submit

September 18, 2009

Conditions

Enteropathy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic NSAID users

You may qualify if:

  • written informed consent
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8550, Japan

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Naoki Ohmiya, MD., Ph.D.

CONTACT

81-52-744-2172nohmiya@med.nagoya-u.ac.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 3, 2009

Study Start

October 1, 2009

Last Updated

September 21, 2009

Record last verified: 2009-09

Locations

JP(1)