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Vonoprazan combined with different doses of tetracycline dual therapy for Helicobacter pylori : a multicenter, non-inferiority, randomized controlled trial

Vonoprazan combined with different doses of tetracycline dual therapy for Helicobacter pylori : a multicenter, non-inferiority, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099200
Enrollment
Unknown
Registered
2025-03-19
Start date
2025-03-25
Completion date
Unknown
Last updated
2025-03-24

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 1:Tetracycline 500 mg tid + Vonoprazan 20 mg bid
Group 2:Tetracycline 500 mg qid + Vonoprazan 20 mg bid
Group 3:Amoxicillin 1000 mg qid + Vonoprazan 20 mg bid

Sponsors

Lanzhou University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 70 years; (2) Patients diagnosed with Helicobacter pylori infection positivity by urea breath test; (3) Patients who are either treatment-naïve for H. pylori or have experienced one treatment failure (with the last treatment being more than 3 months ago and the previous treatment regimen being different from the current one); (4) In Groups 1 and 2, participants may or may not be allergic to penicillin, while the control group must not be allergic to penicillin; (5) Willing to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Women in the preconception period, pregnant women, or breastfeeding women;(2) Individuals who have taken medications within the past 3 months that may affect the study results (proton pump inhibitors [PPIs], potassium-competitive acid blockers, H2 receptor antagonists [H2RAs], bismuth agents, antibiotics, antisecretory drugs, etc.);(3) Patients with =2 treatment failures for H. pylori or those who experienced one previous treatment failure with a regimen identical to the current study protocol;(4) Patients with severe systemic diseases or malignancies;(5) Patients who have previously undergone gastric or esophageal surgery;(6) Known contraindications to any of the drugs used in this study;(7) Patients who, due to advanced age, psychiatric or psychological abnormalities, or other reasons, are unable to describe adverse events.

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 ContactDe-Kui Zhang

Lanzhou University Second Hospital

sczdk1972@163.com+86 139 0931 8616

Outcome results

None listed

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