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Comparing vonoprazan combined with amoxicillin different-dose amoxicillin dual therapy for Helicobacter pylori infection: a prospective multicenter randomized controlled clinical study

Comparing vonoprazan combined with amoxicillin different-dose amoxicillin dual therapy for Helicobacter pylori infection: a prospective multicenter randomized controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065282
Enrollment
Unknown
Registered
2022-11-01
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Helicobacter pylori infection

Interventions

Standard dose routine administration group:Vonolaxan fumarate 20mg/ time, bid+ amoxicillin 500mg/ time, qid, treatment course for 14 days.
High dose and high frequency administration group:Vonorasone fumarate 20mg/ time, bid+ amoxicillin 750mg/ time, qid, the course of treatment is 14 days.
High-dose and low-frequency administration group:High-dose and low-frequency administration group: Voronol fumarate 20mg/ time, bid+ amoxicillin 1g/ time, tid, the course of treatment was 14 days.

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients, aged between 18 and 70 years. 2. He did not take antibiotics, bismuth and traditional Chinese medicine for 4 weeks before treatment, and did not take PPI, H2 receptor antagonist and other drugs affecting Hp activity for 2 weeks. 3. The patient was first diagnosed as HP positive by C13 or C14-urea breath test, rapid urease test and histopathology, and had not received Hp eradication therapy before. 4. The patient underwent gastroduodenoscopy within 1 year. 5. Patients were informed and agreed to participate in this study, and their medical records and follow-up records were complete.

Exclusion criteria

Exclusion criteria: 1. Patients with systemic lupus erythematosus, acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection, or positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or HCVRNA test; Creatinine >2mg/dL(>177umol/L); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 2 times the upper limit of normal or total bilirubin > 2 times the upper limit of normal; Or have significant history or clinical manifestations of central nervous system, cardiovascular, lung, liver, kidney, metabolic, other gastrointestinal, urinary, endocrine or hematological diseases; 2. the presence of penicillin, amoxicillin or voronaxan drug allergy; 3. Patients with gastrointestinal tumors, gastrointestinal bleeding and other organic lesions; 4. people with mental diseases and communication disorders; 5. Pregnancy and lactation; 6. are participating in other clinical experimenters.

Design outcomes

Primary

MeasureTime frame
Carbon 14 numerical;

Secondary

MeasureTime frame
Compliance index;

Countries

China

Contacts

Public ContactChangping Li

Affiliated Hospital of Southwest Medical University

506854209@qq.com+86 13882731666

Outcome results

None listed

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