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
Starting soon · Phase 4
Conditions studied: Helicobacter Infection, Vonoprazan, Amoxicillin
In brief
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.
Key facts
- Study ID
- NCT07720037
- Run by
- Shandong University
- People needed
- 232
- Starts
- 2026-07-30
- Expected to finish
- 2028-05-30
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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