Vonoprazan-Amoxicillin Dual Sequential Therapy For Helicobacter Pylori-infected Treatment-naive Patients:A Randomized, Open-label, Parallel-controlled , Multicenter Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Feng Ye, PhD
fengye@njmu.edu.cn
86+13815897873
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 600
Treatments
Experimental: 14-day Vonoprazan-Amoxicillin dual sequential therapy
First 7 days (Day 1 to Day 7): 20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily; Last 7 days (Day 8 to Day 14): 20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily.
Experimental: 10-day Vonoprazan-Amoxicillin dual sequential therapy
First 5 days (Day 1 to Day 5): 20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily; Last 5 days (Day 6 to Day 10): 20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily.
Active_comparator: 14-day Vonoprazan-Amoxicillin dual therapy
20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 14 days.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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