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Comparison of Triple vs. Quadruple Therapies for First-Line H. pylori Eradication
NCT01906879Phase 4
Key facts
- Status
- Unknown
- Start
- Jun 2013
- Primary completion
- Dec 2017
- Countries
- 1
- Sponsor
- National Taiwan University Hospital
- Modality
- DNA Intercalators/Alkylators
- Conditions
- Helicobacter pylori infection
01
Overview
Phase 4, randomised, open-label trial of metronidazole, bismuth subcitrate and tetracycline in Helicobacter pylori infection (3 arms), sponsored by National Taiwan University Hospital. Primary endpoint: Eradication rate for H. pylori at 6 weeks. Status: unknown.
02
Design
3 arms- Study design
- RandomizedOpen-label
Triple Therapy
Lansoprazole + Clarithromycin + Amoxicillin for 14 days
Non-bismuth Quadruple
Lansoprazole + Amoxicillin + Clarithromycin + Metronidazole for 10 days
Bismuth Quadruple
Lansoprazole + Bismuth + Metronidazole + Tetracycline for 10 days
03
Who it enrols
Adult patients (>20 years) with H. pylori infection, naive to eradication therapy, excluding those with gastrectomy, gastric malignancy, severe concurrent diseases, or allergies to study drugs.
04
Endpoints
Primary
Eradication rate for H. pylori
Secondary
Adverse effects of each treatments
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