The Effect of Rebamipide for Non-steroidal Anti-inflammat... | NCT00862628

Studies
The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries

NCT00862628

Sponsor

Nagoya University

Status

Unknown status

Last Update Posted

Sep 21, 2009Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

NSAIDs-induced Small-intestinal Injuries

Interventions

Rebamipide

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

Jun 2010Estimated

Completion Date

Oct 2010Estimated

First Submitted Date

Mar 16, 2009

First Submission Date that Met QC Criteria

Mar 16, 2009

First Posted Date

Mar 17, 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 efficacy of rebamipide for NSAID-induced small-intestinal injuries.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rebamipide	Experimental		Drug: Rebamipide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rebamipide	Drug	100mg tid, 4 or 8 weeks	Rebamipide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of mucosal breaks		4 and 8 weeks after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
20 to 85 years of age
RA, OA, or low back pain
No change of drugs before 3 months
Under 5 mg of corticosteroid use
CRP < 1mg/dl
Small-intestinal mucosal injuries more than one
Hemoglobin level is below normal range

Exclusion Criteria:

Known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
Prostaglandins, metronidazole or salazosulfapyridine
Can not swallow
Eith pacemaker
After gastrointestinal operation
Serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease.
Taking rebamipide before one week
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

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

Name	Affiliation	Role
Naoki Ohmiya, M.D., Ph.D.	Nagoya University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Nagoya University Graduate School of Medicine		Nagoya	Aichi-ken	466-8550	Japan

Intervention Browse Module

MeSH Terms

ID	Term
C052785	rebamipide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided