drugset / Trial / NCT07179159
Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial
Recruiting
372 enrolled
Yanqing Li
Dezhou Hospital Qilu Hospital of Shandong University · collabDongying No. 2 People's Hospital · collabGuanxian County People's Hospital · collabLongkou People's Hospital · collabQilu Hospital of Shandong University · collabQingdao Jimo People's Hospital · collabShandong University of Traditional Chinese Medicine · collabYantai Zhifu Hospital · collabZibo Maternal and Child Health Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.
Timeline
- Start
- 2025-09-09
- Primary completion
- 2026-08-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bismuth Potassium Citrate | Unknown | 220 mg | — |
| Comparator | Clarithromycin | Small molecule | 500 mg | — |
| Comparator | Levofloxacin | Small molecule | 500 mg | — |
| Background | Amoxicillin | Other / unclassified | 1000 mg | — |
| Background | Vonoprazan | Other / unclassified | 20 mg | — |