Helicobacter Pylori and Vonoprazan Dual Therapy
NCT05649709 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 504
Last updated 2024-08-23
Summary
Our previous study included 119 Helicobacter pylori(H. pylori)-infected Chinese patients without previous eradication history who were randomized to low-or high-dose amoxicillin-vonoprazan regimens consisting of amoxicillin 1 gram either b.i.d. or t.i.d plus vonoprazan 20 mg b.i.d for 7 or 10 days. Neither 7-or 10-day VA dual therapy with either b.i.d. or t.i.d. amoxicillin achieved satisfied efficacy (i.e., \<90%) when given as first-line treatment for H. pylori infection. This study evaluated the efficacy and safety of low-and high-dose amoxicillin-vonoprazan dual therapy for 14 days as first-line treatment for H. pylori in China.
Conditions
- Helicobacter Pylori
Interventions
- DRUG
-
L-VA dual therapy
1000mg amoxicillin capsules twice times daily and 20mg vonoprazan Fumarate Tablets twice daily for 14 days
- DRUG
-
H-VA dual therapy
1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 14 days
Sponsors & Collaborators
-
The First Affiliated Hospital of Nanchang University
lead OTHER
Principal Investigators
-
Nong-Hua Lu, phD · The First Affiliated Hospital of Nanchang University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-02-13
- Primary Completion
- 2024-01-25
- Completion
- 2024-01-25
Countries
- China
Study Locations
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