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Community-based Helicobacter Pylori Eradication in High-risk Area for Gastric Cancer
NCT00155389Phase 4
Key facts
- Status
- Unknown
- Start
- Jan 2004
- Primary completion
- Dec 2015
- Countries
- 1
- Sponsor
- National Taiwan University Hospital
- Modality
- Small Molecules
- Conditions
- Helicobacter pylori infection
01
Overview
Phase 4, open-label, single-arm trial of esomeprazole, amoxicillin, clarithromycin and levofloxacin in Helicobacter pylori infection, sponsored by National Taiwan University Hospital. Primary endpoints: Successful helicobacter eradication at 12 years, Change in premalignant gastric lesion at 12 years and 1 more. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
H pylori eradication
All enrolled subjects received chemoprevention with Helicobacter pylori eradication
03
Who it enrols
Includes subjects with Helicobacter pylori infection. Excludes pregnant women and those with prior gastrectomy.
04
Endpoints
Primary
Successful helicobacter eradication
Change in premalignant gastric lesion
Change in gastric cancer incidence rate
Secondary
Intragastric histologic change
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