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A randomized controlled trial of Vonoprazan combined with amoxicillin as a first- line treatment for Helicobacter pylori infection

A randomized controlled trial of Vonoprazan combined with amoxicillin as a first- line treatment for Helicobacter pylori infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048163
Enrollment
Unknown
Registered
2021-07-04
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

Helicobacter pylori infection

Interventions

Experimental group A:esomeprazole 20mg 2/day, bismuth 220mg 2/day, amoxicillin 1g 2/day, clarithromycin 500mg 2/day. The course of treatment was 10 days
Experimental group B:VPZ 20 mg 2/day and Amoxicillin 1g 2/day for 10 days
Experimental group C:VPZ 20 mg 2/day and Amoxicillin 750mg 4/day for 10 days

Sponsors

Jiangsu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years; 2. Chronic gastritis with or without healed duodenal or stomach ulcer; 3. H. pylori (+) determined by C13 or C14; 4. Treatment-naive patients for eradication of H. pylori infection.

Exclusion criteria

Exclusion criteria: 1. Allergy to medications used in this clinical trial; 2. Use of PPI, histamine H2-receptor antagonists, antibiotics, bismuth, or probiotics 4 weeks before initiating study treatment; 3. Use of adrenocorticosteroids, nonsteroidal anti-inflammatory drugs, and anticoagulants; 4. Alcohol abuse; 5. Presence of diseases or clinical conditions, such as liver disease, cardiac vascular disease,lung disease, kidney disease, metabolic disease, mental illness, or malignant tumors, that might interfere with the evaluation of study treatment; 6. Female patients planning pregnancy, as well as pregnant and breastfeeding patients; 7. Previous esophageal or stomach surgical procedures; 8. Participation in other clinical studies within 3 months before enrollment in this clinical study; 9. Incomplete follow-up or noncompliance with the study treatment; 10. Patients who cannot sign informed consent.

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
Patient compliance;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactZhang guoxin

Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University

guoxinz@njmu.edu.cn+86 13951913128

Outcome results

None listed

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