Clinical Assessment to Establish the Symptomatic Advantage of Rabeprazole: double-blind, randomized, placebo-controlled study in functional dyspepsia

UMIN ID: UMIN000001124

Registered date:29/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Functional Dyspepsia
• Date of first enrollment: 2008/04/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

rabeprazole
placebo

Outcome(s)

• Primary Outcome: Severity of dyspeptic symptoms by Gastrointestinal Symptoms Rating Scale (GSRS)
• Secondary Outcome: Patients' Background QOL evaluation by SF-8 Anti-H. pylori IgG Serum pepsinogen I, pepsinogen II

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Organic disease such as reflux esophagitis (> grade A) and erosive gastritis. 2. Patients with past history of gastrectomy 3. NSAIDs or low-dose aspirin -related dyspepsia 4. Patients with organic disease in the brain or with psychological disorders 5. Patients with alcoholics or with drug dependence 6. Severe endocrine disease including hyperthyroidism 7. Severe diseases in heart, liver and kidney. Severe infectious or hemotological diseases 8. Drug allegy for rabeprazole 9. expectant mother, mother with breast-feeding 10. other not applicable person recognized by a doctor

Related Information

• Primary Sponsor: Office of CAESAR study
• Secondary Sponsor: Group for CAESAR study
• Source(s) of Monetary Support: Donation