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10-day vonoprazan and high-dose amoxicillin dual therapy versus 14-day high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori eradication: A multicenter, open-label, randomized controlled trial

10-day vonoprazan and high-dose amoxicillin dual therapy versus 14-day high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori eradication: A multicenter, open-label, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070475
Enrollment
Unknown
Registered
2023-04-12
Start date
2023-04-25
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

helicobacter pylori

Interventions

10-day vonoprazan-amoxicillin dual therapy group:vonoprazan 20mg bid + amoxicillin 1000mg tid
14-day high-dose esomeprazole-amoxicillin dual therapy group:esomeprazole 20mg bid + amoxicillin 750mg qid

Sponsors

Affiliated Hospital of Yangzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients, aged 18-70 years, no gender limit; 2. H. pylori-infected patients diagnosed with 13C-Urea breath test (UBT) or 14C-UBT; 3. Did not receive standardized H. pylori eradication therapy; 4. Participate in the study voluntarily and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to the drug under study (amoxicillin, Vonorazone or esomeprazole); 2. Used antibiotics and bismuth in the last 4 weeks, or took PPI in the last 2 weeks; 3. Patients with serious heart, lung, liver, kidney and other diseases and low immunity; 4. Patients with acute upper gastrointestinal bleeding, gastrointestinal malignant tumor, Zhuo-Ai syndrome, gastric cancer surgery history; 5. During pregnancy or lactation; 6. Those who suffer from mental illness or cognitive impairment and cannot cooperate.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Adverse events;Compliance;Intestinal microbiota;Detection of drug resistance genes in Helicobacter pylori;

Countries

China

Contacts

Public ContactDing Yanbing

Department of Gastroenterology, Affiliated Hospital of Yangzhou University

ybding@yzu.edu.cn+86 13773582299

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026