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A clinical study of the efficacy and safety of the combined combination of vonorasen/amoxicillin dual regimen in the management of Helicobacter pylori eradication in the elderly population

A clinical study of the efficacy and safety of the combined combination of vonorasen/amoxicillin dual regimen in the management of Helicobacter pylori eradication in the elderly population

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085862
Enrollment
Unknown
Registered
2024-06-20
Start date
2024-06-25
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Helicobacter pylori infection

Interventions

Group A (Experimental Group):Vonolasan 20 mg bid + amoxicillin 1 g tid with multiple administration
Group B (control group):Esomeprazole 20mg bid + Bismuth potassium citrate 220mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid with multiple administration

Sponsors

Mianyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: The included patients should meet the following conditions at the same time: (1) elderly patients aged > 60 years old and < 75 years old, (2) positive 13/14C rapid urease breath test or Helicobacter pylori antibody test positive and not treated for eradication, (3) meet the indications for HP eradication recommended in the Fifth National Consensus Report on the Treatment of Helicobacter Pylori Infection, (4) outpatients and inpatients, and (5) sign informed consent.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following conditions are excluded from this study. (1) Patients with malignant tumors or gastric ulcers, (2) those who have undergone previous gastric surgery, (3) those who are not willing to participate in the study, (4) those who have had previous cephalosporin allergy or other adverse reactions and cannot tolerate them, (5) those who have had a history of liver and kidney insufficiency, (6) patients who have used any antibacterial drugs, proton pump inhibitors, bismuth agents, and traditional Chinese medicines alone or in combination in the first two weeks of treatment.

Design outcomes

Primary

MeasureTime frame
13/14C rapid urease breath test;Symptomatic remission;

Secondary

MeasureTime frame
Adverse events;

Countries

China

Contacts

Public ContactXinhua Zhao

Mianyang Central Hospital

22481178@qq.com+86 139 8013 7212

Outcome results

None listed

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