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A multicenter randomized controlled study of modified vonoprazan combined with high-dose amoxicillin therapy for first-line eradication of Helicobacter pylori

A multicenter randomized controlled study of modified vonoprazan combined with high-dose amoxicillin therapy for first-line eradication of Helicobacter pylori

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079754
Enrollment
Unknown
Registered
2024-01-11
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-10-21

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:VPZ 20 mg 2/day and Amoxicillin 1000mg 3/day for 7 days
Experimental group B:VPZ 20 mg 2/day and Amoxicillin 750mg 4/day for 7 days
Experimental group C:VPZ 20 mg 2/day and Amoxicillin 1000mg 3/day for 10 days
Experimental group D: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 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Chronic gastritis confirmed HP(+) by gastroscopy within three months, and patients who met the indications of recommended eradication of Helicobacter pylori in the Sixth National Consensus Report on the Treatment of Helicobacter Pylori Infection; 3. H. pylori (+) determined by C13 or C14; 4. Treatment-naive patients for eradication of H. pylori infection. 5. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Allergy to medications used in this clinical trial; 2. Use of vonoprazan,PPI, histamine H2-receptor antagonists, antibiotics, bismuth, or probiotics 1 months before initiating study treatment; 3.Female patients planning pregnancy, as well as pregnant and breastfeeding patients; 4. Use of adrenocorticosteroids, nonsteroidal anti-inflammatory drugs, and anticoagulants; 5. Presence of diseases or clinical conditions, such as cardiac vascular disease,lung disease, liver disease,kidney disease, metabolic disease, mental illness, or malignant tumors, that might interfere with the evaluation of study treatment; 6. Previous esophageal or stomach surgical procedures; 7. Incomplete follow-up or noncompliance with the study treatment;

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+86 139 5191 3128

Outcome results

None listed

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