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Exploration of vonoprazan-amoxicillin in the treatment of Helicobacter pylori

Exploration of vonoprazan-amoxicillin in the treatment of Helicobacter pylori

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098029
Enrollment
Unknown
Registered
2025-02-28
Start date
2024-07-27
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Helibacter Pylori Infection

Interventions

Group 1:Treatment of Helicobacter pylori infection: Group A: traditional bismuth quadruple, including esomeprazole (AstraZeneca, London, UK) 20 mg, twice a day
bismuth potassium citrate capsules (Livzon Group, Zhuhai, China) 220 mg, twice a day
amoxicillin capsules (United Pharmaceuticals, Zhuhai, China) 1000 mg, twice a day
clarithromycin capsules (Abbott Pharmaceuticals, Shanghai, China) 500 mg, twice a day
treatment course of 14 days.
Group 2:Group B: vonoprazan-amoxicillin dual combination, including amoxicillin capsules (United Pharmaceuticals, Zhuhai, China) 1000 mg, twice a day
vonoprazan fumarate tablets (Takeda Pharmaceuticals, Tokyo, Japan) 20 mg, twice a day, treatment course of 14 days.

Sponsors

Peking University International Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years, male or female; (2) Helicobacter pylori infection diagnosed by 13/14C-urea breath test (13/14C-UBT) or stool H pylori antigen detection or immunohistochemical staining of biopsy specimens; (3) Provided informed consent for participation in this study.

Exclusion criteria

Exclusion criteria: (1)No previous history of Hp eradication treatment;(2) History of taking antibiotics, bismuth, or traditional Chinese medicines with antibacterial effects within one month, and taking PPI, H2 receptor antagonists or other drugs that affect Hp activity within two weeks;(3) Serious diseases or clinical conditions such as liver disease, lung disease and cardiovascular disease;(4) Allergy to penicillin or other drugs used in this clinical trial;(5) Pregnancy or lactation;(6) Patients with severe gastrointestinal diseases, such as malignant tumors, gastrointestinal bleeding, or Zoe syndrome, after subtotal gastrectomy;(7) Patients who were assessed by the researcher and were not considered suitable for enrollment due to low compliance or safety reasons.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
incidence rate of adverse reactions;

Countries

China

Contacts

Public ContactFAN XUE

Peking University International Hospital

fanxue0506@163.com+86 138 1183 9400

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026