The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID)

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.

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Detailed Description

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Conditions

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NSAIDs-induced Small-intestinal Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rebamipide

Group Type EXPERIMENTAL

Rebamipide

Intervention Type DRUG

100mg tid, 4 or 8 weeks

Interventions

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Rebamipide

100mg tid, 4 or 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No