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Recruiting NCT07179159

Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial

No phase Interventional HELICOBACTER PYLORI INFECTIONS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 14-day vonoprazan-amoxicillin dual therapy, 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy, 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy.
Who it may be relevant to
Registry conditions: HELICOBACTER PYLORI INFECTIONS. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.

Interventions

  • Drug 14-day vonoprazan-amoxicillin dual therapy
    vonoprazan 20mg bid + amoxicillin 1000mg bid
  • Drug 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy
    vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid
  • Drug 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy
    vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid

Primary outcome measures

  • eradication rate [Time frame: 6 weeks after treatment]
Secondary outcome measures (2)
  • adverse events [Time frame: immediately after a 2-week treatment]
  • compliance [Time frame: immediately after a 2-week treatment]

Eligibility criteria

Inclusion criteria

  • Aged 18-70 years, male or female
  • Patients with H. pylori infection (positive 13C-urea breath test, together with at least one positive result from the following three tests: (a) stool H. pylori antigen test; (b) rapid urease test; (c) histopathological examination of gastric mucosal biopsy tissue)
  • No prior Helicobacter pylori eradication therapy

Exclusion criteria

  • Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours
  • Active gastrointestinal bleeding
  • History of upper gastrointestinal surgery
  • History of drug hypersensitivity
  • Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks
  • Pregnant or lactating women
  • Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use
  • Individuals unable or unwilling to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Qilu Hospital of Shandong University — Jinan
  • Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT07179159 · 202509

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗