VA Dual Sequential Therapy
Vonoprazan-Amoxicillin Dual Sequential Therapy For Helicobacter Pylori-infected Treatment-naive Patients：A Randomized, Open-label, Parallel-controlled , Multicenter Clinical Trial
The First Affiliated Hospital with Nanjing Medical University
600 participants
Apr 24, 2025
INTERVENTIONAL
Conditions
Summary
Sequential therapy for Hp was first introduced by Zullo et al. in 2000 and consists of two phases: the first phase involves proton pump inhibitors with one antibiotic, and the second phase involves proton pump inhibitors with two antibiotics. Based on this, the investigators propose a modified sequential therapy, where the first phase uses vonoprazan combined with amoxicillin, and the second phase increases the amoxicillin dosage, forming a high-dose amoxicillin regimen. This new treatment strategy combines the staged nature of sequential therapy with the advantages of high-dose dual therapy, gradually increasing the drug dosage to help patients adapt and reduce side effects (such as nausea, vomiting, and diarrhea), thereby improving patient tolerance. The primary aim of this study is to compare the vonoprazan combined with high-dose amoxicillin sequential therapy with standard dual therapy (14-day regimen) in terms of Hp eradication rates, efficacy, side effect incidence, and patient compliance, to evaluate its improved effectiveness. Additionally, the study will explore the impact of a shortened treatment duration on the modified dual sequential therapy's efficacy for Hp infection. Eligible participants in this study will be randomly assigned to one of the following three treatment groups based on a pre-generated randomization sequence: Control Group: Vonoprazan combined with high-dose amoxicillin dual therapy for 14 days (VADT-14): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily. Experimental Group 1: Vonoprazan combined with amoxicillin dual sequential therapy for 14 days (VAST-14): Days 1 to 7: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 8 to 14: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily. Experimental Group 2: Vonoprazan combined with amoxicillin dual sequential therapy for 10 days (VAST-10): Days 1 to 5: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 6 to 10: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.
Eligibility
Inclusion Criteria4
- Aged 18-70 years, gender unrestricted.
- Chronic gastritis patients with Helicobacter pylori positivity: (1) Helicobacter pylori positive is defined as a positive result on a carbon-13 or carbon-14 breath test within one month prior to enrollment; (2) Chronic gastritis is defined as a diagnosis based on gastroscopy within six months prior to enrollment.
- No previous Helicobacter pylori eradication therapy.
- Agree to participate in the trial and sign the informed consent form
Exclusion Criteria11
- Allergy to any of the drugs used in this clinical trial.
- Previously received H. pylori eradication treatment.
- Receiving Potassium-competitive acid blocker (P-CAB), proton pump inhibitor (PPI), H2 receptor antagonist, antibiotics, bismuth, probiotic preparations 4 weeks before initiating study treatment.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs), adrenal corticosteroids, or anticoagulants during the study period.
- Pregnant or lactating women, or patients planning to conceive during the study period.
- Patients with hepatic or renal dysfunction, or those with severe concomitant diseases that may affect the evaluation of this study, such as heart disease, lung disease, liver disease, kidney disease, metabolic disorders, mental illnesses, malignant tumors, etc..
- Gastroscopy findings indicating conditions other than gastritis, such as reflux esophagitis, which require continued use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H2 receptor antagonists, or bismuth after Helicobacter pylori eradication.
- Patients with a history of gastric surgery.
- Patients who are unable to accurately express their symptoms, such as those with psychiatric disorders or severe neurosis, and are unable to cooperate with the trial.
- Patients who have participated in other drug studies within 3 months before using the investigational drug.
- Other conditions deemed by the investigator as unsuitable for participation in this trial.
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Interventions
20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily for 7 days
20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily for 5 days
20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 7 days
20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 5 days
20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 14 days
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06929962