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NCT Number: NCT07352098

7-day High-Dose Vonoprazan-amoxicillin Dual Therapy Versus 14-day Vonoprazan-amoxicillin Dual Therapy for H. Pylori

Helicobacter pylori infection is a prevalent global gastrointestinal condition linked to chronic gastritis, peptic ulcer disease, and gastric cancer. Potent and sustained acid suppression improves eradication efficacy. Vonoprazan, a potassium-competitive acid blocker, provides rapid and stable acid inhibition and has become an important component of dual therapy with amoxicillin. However, the optimal dosing strategy and treatment duration for vonoprazan-based dual therapy are not yet fully established.

This multicenter, open-label, randomized controlled trial compares the efficacy and safety of a short-term, high-dose vonoprazan-based dual therapy (20 mg three times daily for 7 days) with a standard-dose regimen (20 mg twice daily for 14 days), both combined with amoxicillin, for first-line H. pylori eradication. Adult participants with confirmed H. pylori infection will be randomized 1:1 to the two treatment groups. The primary outcome is the eradication rate of H. pylori at 6 weeks after completion of therapy. Secondary outcomes include safety assessments and medication adherence. This study will provide evidence on whether a higher dose and shorter treatment course can achieve similar eradication rates with acceptable safety and tolerability compared to the standard regimen.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-70 years, no gender restrictions;
  • Patients with H. pylori infection confirmed by 13C/14C-urea breath test ;
  • No prior history of H. pylori eradication therapy;

Exclusion criteria

  • Patients allergic to study medications (vonoprazan fumarate, amoxicillin);
  • Patients with active qastrointestinal bleeding,;
  • Patients undergone or scheduled to undergo surgery within 1 month prior to randomization or during the study period that may affect gastric acid secretion (e.g., gastric surgery, vagotomy, or craniotomy);
  • Patients underlying severe medical conditions deemed by the investigator to potentially confound study results or compromise subject safety, such as: hepatic impairment (ALT or AST > 1.5 times the upper limit of normal); renal impairment (Cr ≥ 2.0 mg/dL or eGFR < 50 mL/min/1.73 m²); immunosuppression; malignancy; severe central nervous system, cardiovascular, or respiratory disease;
  • Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitors within 2 weeks;
  • Patients with behaviors potentially increasing disease risk: history of chronic substance abuse or alcohol dependence within 12 months prior to screening;
  • Patients planning pregnancy, currently pregnant, breastfeeding, or unwilling to use contraception during the trial period;
  • Patients unable or unwilling to provide informed consent.

Treatment and study plan

7-day high-dose vonoprazan-amoxicillin dual therapy group

Drug

Patients in the 7-day high-dose vonoprazan-amoxicillin dual therapy group received vonoprazan fumarate tablets 20 mg three times daily, administered 30 minutes before meals, and amoxicillin 1,000 mg three times daily, taken after meals.

Both medications were administered orally for 7 consecutive days.

14-day vonoprazan-amoxicillin dual therapy group

Drug

Patients in the 14-day vonoprazan-amoxicillin dual therapy group received vonoprazan fumarate tablets 20 mg twice daily, administered 30 minutes before meals, and amoxicillin 1,000 mg three times daily, taken after meals.

Both medications were administered orally for 14 consecutive days.

Primary outcomes

  1. Eradication rate

    Time frame: 6 weeks after treatment

Secondary outcomes

  1. incidence of adverse events

    Time frame: immediately after treatment

Sponsors and collaborators

Lead sponsor

Yueyue Li

Other

Collaborators

  • Guanxian County People's Hospital
  • Kashi Prefecture Hospital of Traditional Chinese Medicine
  • Qilu Hospital of Shandong University
  • Qilu Hospital of Shandong University, Dezhou Branch
  • Shandong University of Traditional Chinese Medicine
  • Yantai Zhifu Hospital
  • Zaozhuang Municipal Hospital

Registry information

Official study title

Efficacy and Safety of Short-Term, High-Dose Vonoprazan-Based Dual Therapy Versus Standard-Dose Vonoprazan-Based Dual Therapy for Helicobacter Pylori Eradication: A Multicenter, Open-Label, Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jan 20, 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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