Follow-up Study of Small-intestinal Mucosal Injuries in C... | NCT00854490

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

NCT00854490

Sponsor

Nagoya University

Status

Unknown status

Last Update Posted

Sep 21, 2009Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Enteropathy

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 2, 2009

First Submission Date that Met QC Criteria

Mar 2, 2009

First Posted Date

Mar 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2009

Last Update Posted Date

Sep 21, 2009Estimated

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Chronic NSAID users

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Naoki Ohmiya, MD., Ph.D.	Contact	81-52-744-2172		nohmiya@med.nagoya-u.ac.jp

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nagoya University Hospital		Nagoya	Aichi-ken	466-8550	Japan

Condition Browse Module

MeSH Terms

ID	Term
D007410	Intestinal Diseases

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided