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Vonoprazan and high-dose amoxicillin dual therapy as first-line Helicobacter pylori treatment: a multicenter, prospective, randomized, open-label trial

Vonoprazan and high-dose amoxicillin dual therapy as first-line Helicobacter pylori treatment: a multicenter, prospective,randomized, open-label trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070100
Enrollment
Unknown
Registered
2023-04-02
Start date
2023-04-02
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

control group:Bismuth-Containing Quadruple Therapy: 10 mg of rabeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 200 mg of colloidal bismuth twice daily for 14 days.
experimental group:Dual Therapy: 20 mg of vonoprazan twice daily and 1 g of amoxicillin 3 times daily for 10 days.

Sponsors

The First Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.participants aged 18–70 years; 2. absent history of receiving H.pylori eradication therapy; 3.confirmed H. pylori infection by at least 1 of the following tests: urea breath test, histology examination, and positive bacterial culture.

Exclusion criteria

Exclusion criteria: 1. Used antibiotics,bismuth,or acid inhibitor use, including H2 receptor antagonist, PPI or P-CAB within four weeks before inclusion; 2. Current pregnancy or breastfeeding; 3. Allergy to any of the study drugs; 4. History of gastrectomy; 5. Gastric malignancy; 6. Gastroduodenal ulcer with recent hemorrhage or signs of hemorrhage within 4 weeks; 7. Preexisting serious diseases or clinical conditions that might interfere with the evaluation of study treatment; 8. Hepatic or renal dysfunction; 9. Patients with prolonged QT interval, a history of ventricular arrhythmia, or hypokalemia; 10. Administration of astemizole, cisapride, pimozide, terfenadine, ergotamine/Dihydroergotamine, oral midazolam, colchicine, ticagrelor/ranolazine, statins, azanavir, or lipivirin during the trial.

Design outcomes

Primary

MeasureTime frame
Eradication rates of Helicobacter pylori;

Secondary

MeasureTime frame
adverse events;compliance;

Countries

China

Contacts

Public ContactTianlian Yan

The First Affiliated Hospital, Zhejiang University School of Medicine

583195088@qq.com+86 134 8638 8649

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026