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

Tokai National Higher Education and Research System

Status: Unknown

Conditions: NSAIDs-induced Small-intestinal Injuries

Treatments: Drug: Rebamipide

Study type: Interventional

Funder types: Other

Identifiers

NCT00862628

NO-003

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 1 patient group

Rebamipide

Experimental group

Treatment:

Drug: Rebamipide