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NCT Number: NCT07720037

Efficacy Comparison of 10-Day High-Dose Versus 14-Day Standard-Dose Vonoprazan Plus Amoxicillin in Helicobacter Pylori Eradication: A Multicenter Non-Inferiority Randomized Controlled Trial

This is a multicenter non-inferiority randomized controlled trial for patients infected with Helicobacter pylori. Eligible participants will be randomly split into two groups. One group will take high-dose vonoprazan combined with amoxicillin (vonoprazan 20mg tid, amoxicillin 1000mg bid) for 10 days, while the other group will receive standard-dose vonoprazan plus amoxicillin (vonoprazan 20mg bid, amoxicillin 1000mg bid) for 14 days. The main goal of this study is to compare how well the two treatment plans clear the H. pylori bacteria. We aim to check if the 10-day high-dose treatment works no worse than the 14-day standard treatment. Every participant will take a follow-up test after treatment to see if the bacteria have been eliminated.

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Key information

Conditions

Helicobacter Infection Amoxicillin Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Helicobacter Infections Infections Vonoprazan

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 to 70 years, no restriction on gender
  • Current Helicobacter pylori infection (positive result of either ¹³C or ¹⁴C urea breath test)
  • No prior history of Helicobacter pylori eradication therapy

Exclusion criteria

  • Severe underlying diseases, including hepatic insufficiency, renal insufficiency, malignant tumors, etc.
  • Active gastrointestinal bleeding
  • History of upper gastrointestinal surgery
  • History of allergy to study medications
  • Use of bismuth agents or antibiotics within 4 weeks prior to enrollment; use of acid-suppressive agents within 2 weeks prior to enrollment
  • Pregnant or breastfeeding women, and subjects who refuse to take contraceptive measures during the trial
  • Behaviors that may increase disease risks, such as chronic alcohol abuse and drug addiction
  • Subjects who are unable or unwilling to sign the informed consent form

Treatment and study plan

10-day group

Drug

vonoprazan 20mg tid and amoxicillin 1000mg tid for 10 days

14-day group

Drug

vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days

Primary outcomes

  1. Eradication rates

    Time frame: immediately after the procedure

    Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medicines. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

Secondary outcomes

  1. Rate of adverse reactions

    Time frame: immediately after the procedure

  2. Patient compliance

    Time frame: immediately after the procedure

    Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Comparison of Eradication Efficacy Between 10-Day High-Dose Vonoprazan and 14-Day Standard-Dose Vonoprazan Combined With Amoxicillin for Helicobacter Pylori: A Multicenter, Non-Inferiority Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 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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