A multi-center prospective trial comparing Functional Dyspepsia patients with or without Metabolic Syndrome treated with omeprazole
- Conditions
- Functional Dyspepsia
- Registration Number
- JPRN-UMIN000001974
- Lead Sponsor
- Office of DMETS study
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 210
Not provided
1. Endoscopic finding 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 treated with proton pump inhibitors(PPI), H2 receptor antagonists(H2RAs), prokinetic drugs, anticholinergic drugs, antidepressant drugs, antianxiety drugs (within 14 days prior to the screening visit) 5. Patients with organic disease in the brain or with psychological disorders 6. Patients with alcoholics or with drug dependence 7. Severe endocrine disease including hyperthyroidism 8. Severe diseases in heart, liver and kidney. Severe infectious or hemotological diseases 9. Drug allegy for omeprazole 10. Expectant mother, mother with breast-feeding 11. Other not applicable patients recognized by a doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of dyspeptic symtoms by Gastrointestinal Symptom Rating Scale(GSRS)
- Secondary Outcome Measures
Name Time Method Patients' Background QOL evaluation by SF-36 Anti-H. pylori IgG Serum pepsinogen I, pepsinogen II