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Comparison of Single Dose vs Conventional Triple Therapy for H. pylori
NCT02711176Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2016
- Primary completion
- Mar 2017
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- Helicobacter pylori infection
01
Overview
Phase 4, randomised, open-label trial of levofloxacin, tinidazole and esomeprazole in Helicobacter pylori infection (2 arms). Primary endpoint: The rate of H.pylori eradication. Started Sep 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Single Dose Triple Therapy
Esomeprazole 40mg + Tinidazole 1g + Levofloxacin 500mg daily for 14 days
Conventional Triple Therapy
Lansoprazole 30mg + Clarithromycin 500mg + Amoxicillin 1g twice daily for 14 days
03
Who it enrols
Patients with proven H. pylori infection (positive rapid urease test, histology, and stool antigen). Excludes patients with previous eradication therapy, recent antibiotic/PPI use, advanced gastric cancer, liver/renal dysfunction, or pregnancy/lactation.
04
Endpoints
Primary
The rate of H.pylori eradication
Secondary
Drug Compliance
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