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High-dose Dual Therapy with Different Administration Frequencies for H. Pylori
NCT05901051Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2021
- Primary completion
- Sep 2023
- Countries
- 1
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Modality
- Small Molecules
- Conditions
- Helicobacter pylori infection
01
Overview
Phase 4, randomised, open-label trial of vonoprazan and amoxicillin in Helicobacter pylori infection (3 arms), sponsored by Shanghai Jiao Tong University School of Medicine. Primary endpoint: Helicobacter pylori eradication rate. Started Mar 2021; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Dual Therapy A
Vonoprazan 20mg bid ac + Amoxicillin 0.75g qid pc
Dual Therapy B
Vonoprazan 20mg bid ac + Amoxicillin 1g tid pc
Dual Therapy C
Vonoprazan 20mg bid ac + Amoxicillin 1g tid ac
03
Who it enrols
Patients with confirmed H. pylori infection, excluding those with recent antibiotic/PPI use, serious organ dysfunction, or GI malignancies.
04
Endpoints
Primary
Helicobacter pylori eradication rate
Secondary
Rate of adverse events
Compliance rate
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