Controlled comparative study for the efficacy between famotidine and omeprazole on prevention of delayed bleeding from ulcer after ESD for early gastric cancer

UMIN ID: UMIN000001215

Registered date:30/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: early gastric cancer
• Date of first enrollment: 2008/02/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Administration of famotidine 40mg P.O./day for 8weeks
Administration of famotidine 40mg P.O./day for 1day and omeprazole 40mg I.V./day for 3days after ESD and omeprazole 20mg P.O./day for 7weeks and 4 days

Outcome(s)

• Primary Outcome: Retio of delayed bleeding(hematemesis or melena required endoscopic hemostasis, decreased the hemoglobin count by more than 2g/dl)
• Secondary Outcome: The curative rate for ulcer after ESD at 6 weeks later

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. patients with severe liver, renal and cardiopulumonary diseases. 2. patients who took medicines described below within one week before the first day of the study; H2RA, PPI 3. patients who had underwent eradication therapy for H.pylori within 6 months before the first day of the study 4. patients who are pregnancy, in breast-feeding or who wish pregnancy during the study period. 5. patients who are regarded in-eligible by the doctor who participates in this study.

Related Information

• Primary Sponsor: Hyogo College of Medicine Upper gastroenterology Department of internal medicine
• Source(s) of Monetary Support: Hyogo College of Medicine