The prevention effect in renal disease patients taking a oral steroid with the rebamipide or the rabeprazole- a randomized control study-

UMIN ID: UMIN000001611

Registered date:05/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Renal disease
• Date of first enrollment: 2008/01/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

This randomized, single-center study was conducted according to the Declaration of Helsinki. We asked the patients about the following 6 symptoms: early satiety; belching; daytime heartburn; nocturnal heartburn; epigastric pain; or discomfort. All of dyspepsia symptoms were rated by patients on a seven-point categorical scale (0; none, 1: slight, 2: mild, 3: moderate, 4: severe, 5: very severe, 6: worst possible. When patients have a score less than 3 points for 6 symptoms and patients do not have peptic ulcer by endoscopic finding, the participants were randomly divided into three treatment arms in each of the groups. Patients was randomly assigned to receive 100 mg rebamipide 3 times per day after each meal, or 10 mg rabeprazole once a day after breakfast, no taking a drug(Placebo) during 12 months.
When patients have a score greater than 4 points for at least one of the 6 symptoms, patients was randomly assigned to receive 100 mg rebamipide 3 times per day after each meal, or 10 mg rabeprazole once a day after breakfast during 12 months.

Outcome(s)

• Primary Outcome: The current study attempted to compare the efficacy of rabeprazole with rebamipide after 12-week treatment in renal disease patients taking a oral steroid with or without H. pylori infections.
• Secondary Outcome: Gastrointestinal symptom.(Gastrointesitinal Symptom Rating Scale) upper gastrointestinal endoscopy.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients were excluded if patients had been malignant disease, previous upper abdominal surgery, neuropsychiatric disorder, organic brain damage, hepato-renal disorder, cardiopulmonary disorder, symptoms suggesting or were pregnant.

Related Information

• Primary Sponsor: Graduate School of Medicine Science, Kumamoto University
• Source(s) of Monetary Support: Graduate School of Medicine Science, Kumamoto University