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Efficacy, safety, and compliance comparison of vonoprazan combined with different doses of amoxicillin dual therapy for eradication of Helicobacter pylori in the elderly: a prospective, multicenter, randomized controlled study

Efficacy, safety, and compliance comparison of vonoprazan combined with different doses of amoxicillin dual therapy for eradication of Helicobacter pylori in the elderly: a prospective, multicenter, randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063796
Enrollment
Unknown
Registered
2022-09-16
Start date
2022-09-06
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Helicobacter pylori

Interventions

Group 1 :amoxicillin 750 mg qid + vonoprazan 20 mg bid
Group 2:amoxicillin 500 mg qid + vonoprazan 20 mg bid
Group 3:amoxicillin 1 g tid + vonoprazan 20 mg bid

Sponsors

Lanzhou University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Elderly patients, aged 60-80 years; 2. Did not take antibiotics, bismuth and antibacterial active traditional Chinese medicine for 4 weeks before treatment, and did not take PPI, H2 receptor antagonists and other drugs that affect the activity of H.pylor for 2 weeks before treatment; 3. H. pylori infection was diagnosed as positive by 13C/14C urea breath test or rapid urease test or histological examination; 4. Patients have undergone gastroduodenoscopy at least within 1 year; 5. Patients are informed and agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Suffering from systemic lupus erythematosus, acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection, or detection of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or HCV RNA Positive; creatinine level > 2 mg/dL (> 177 µmol/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 affected Subjects have a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urinary, endocrine or hematological diseases that the investigator believes will affect the results of the study or jeopardize subject safety; 2. Those who are allergic to penicillin, amoxicillin or vonolasan; 3. Patients with organic lesions such as gastrointestinal malignant tumors or gastrointestinal bleeding; 4. People with mental illness and communication disorders; 5. Those who are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Comparison of helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Comparison of compliance;Factors influencing eradication rate;

Countries

China

Contacts

Public ContactDekui Zhang

Lanzhou University Second Hospital

zhangdk8616@126.com+86 13919788616

Outcome results

None listed

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