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Vonoprazan plus amoxicillin dual therapy for Helicobacter pylori eradication in central China: A single- center, prospective, open-label, randomized-controlled trial

Vonoprazan plus amoxicillin dual therapy for Helicobacter pylori eradication in central China: A single- center, prospective, open-label, randomized-controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087205
Enrollment
Unknown
Registered
2024-07-22
Start date
2022-10-08
Completion date
Unknown
Last updated
2024-07-29

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:Vonoprazan 20mg twice a day and amoxicillin 1.0g three times a day for 14 days
Group B:Vonoprazan 20mg twice a day and amoxicillin 1.0g three times a day for 10 days
Group C:Vonoprazan 20mg twice a day, amoxicillin 1.0g twice a day and colloidal bismuth pectin 220mg twice a day for 14 days
Group D:Esomeprazole 20mg twice a day, amoxicillin 1.0g twice a day, clarithromycin 0.5g twice a day, colloidal bismuth pectin 220mg twice a day for 14 days

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients who were diagnosed as H. pylori infection by positive13C-urea breath test, serum antibody test or gastroscopy histology examination, and in need to eradicate H. pylori; 2.Adult patients aged between 18 and70 years willing to participate; 3.Informed and agreed to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Use of proton pump inhibitor, bismuth, antibiotics one month before initiating treatment; 2. Previous H. pylori infection treatment history; 3. Previous surgical history of upper gastrointestinal diseases; 4. Pregnant and breastfeeding patients; 5. Presence of severe diseases, such as mental illness, respiratory, heart, liver or kidney diseases, malignant tumors, and other diseases before entering hospital; 6. Alcohol abuse, or other conditions which increase the risk of adverse reaction; 7. Patients are less adherent; 8. Allergy to related medications, or with severe adverse reactions.

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
adverse reaction;adherence;

Countries

China

Contacts

Public ContactSongze Ding

Henan Provincial People’s Hospital

dingsongze@hotmail.com+86 185 3829 7582

Outcome results

None listed

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