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A multi-center randomized controlled trial of Vonoprazan-amoxicillin dual therapy and Esomeprazole-amoxicillin dual therapy in newly treated patients with Helicobacter pylori

A multi-center randomized controlled trial of Vonoprazan-amoxicillin dual therapy and Esomeprazole-amoxicillin dual therapy in newly treated patients with Helicobacter pylori

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069762
Enrollment
Unknown
Registered
2023-03-24
Start date
2022-06-30
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Helicobacter pylori

Interventions

Experimental group:Vonoprazan+Amoxicillin
The control group:Esmeprazole + Amoxicillin

Sponsors

The 945th Hospital of the joint logistics support force
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18 ~ 70 years old, male or female; (2) chronic gastritis confirmed by gastroscopy, with or without healed gastric ulcer or duodenal bulb ulcer; (3) Both urea breath test and Helicobacter pylori culture were positive. (4) No previous H.pylori eradication therapy; (5) The patient or his legal representative signed the informed consent and understood and agreed to follow the study requirements.

Exclusion criteria

Exclusion criteria: (1) PPI, potassium competitive acid blockers, antibiotics, H2 receptor antagonists, bismuth agents, probiotics and other drugs were used within four weeks before treatment; (2) Pregnant or lactating women, patients who had a birth plan during the study period; (3) Simultaneous use of non-steroidal anti-inflammatory drugs, adrenocorticosteroids, anticoagulants and alcohol abuse during treatment; (4) Patients with allergies to the drugs used in this study; (5) Other serious diseases affecting the evaluation of this study, such as severe liver disease, heart disease, kidney disease, malignant tumor, mental disease, etc.; (6) Patients with previous gastric and esophageal surgery; (7) Participated in other drug studies within the previous three months; (8) It is difficult to complete follow-up or there are other factors affecting compliance; (9) Those who cannot sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
Patient compliance;Symptoms of digestive tract were assessed before and after treatment;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactRui Wang

The 945th Hospital of the joint logistics support

saviola1720@sina.com+86 13684469807

Outcome results

None listed

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