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NCT Number: 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

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.

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Key information

Conditions

HELICOBACTER PYLORI INFECTIONS

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University, Jinan, Shandong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

14-day vonoprazan-amoxicillin dual therapy

Drug

vonoprazan 20mg bid + amoxicillin 1000mg bid

14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy

Drug

vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid

14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy

Drug

vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid

Primary outcomes

  1. eradication rate

    Time frame: 6 weeks after treatment

Secondary outcomes

  1. adverse events

    Time frame: immediately after a 2-week treatment

  2. compliance

    Time frame: immediately after a 2-week treatment

    Satisfactory compliance was defined as taking medications with at least 80% of the prescribed dosage. The proportion of patients with satisfactory compliance was calculated among all patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Yueyue Li

CONTACT

[email protected]

+8618560089751

Sponsors and collaborators

Lead sponsor

Yanqing Li

Other

Collaborators

  • Dezhou Hospital Qilu Hospital of Shandong University
  • Dongying No. 2 People's Hospital
  • Guanxian County People's Hospital
  • Longkou People's Hospital
  • Qilu Hospital of Shandong University
  • Qingdao Jimo People's Hospital
  • Shandong University of Traditional Chinese Medicine
  • Yantai Zhifu Hospital
  • Zibo Maternal and Child Health Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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