VA Dual Sequential Therapy

NCT06929962 | Recruiting Phase 4

• 1 other identifier: 2025JSHERO3
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori; Vonoprazan; Amoxicillin; Sequential therapy; Eradication

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate

  Rate of H. pylori successfully eradicated; The confirmation of H. pylori status was evaluated by Urea breath test.

  4-6 weeks after treatment completion

Secondary Outcomes (3)

• Patient compliance

  1 day after treatment completion

• Adverse events

  For the 10-day intervention: assessment on Day 5 and Day 10; For the 14-day intervention: assessment on Day 7 and Day 14.

• Cost-effectiveness ratio

  1 day after the procedure

Study Arms (3)

14-day Vonoprazan-Amoxicillin dual sequential therapy

EXPERIMENTAL

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.

Drug: Vonoprazan and Amoxicillin for the first 7 days; Drug: Vonoprazan and Amoxicillin for the second 7 days

10-day Vonoprazan-Amoxicillin dual sequential therapy

EXPERIMENTAL

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.

Drug: Vonoprazan and Amoxicillin for the first 5 days; Drug: Vonoprazan and Amoxicillin for the second 5 days

14-day Vonoprazan-Amoxicillin dual therapy

ACTIVE COMPARATOR

20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 14 days.

Drug: Vonoprazan and Amoxicillin for 14 days

Interventions

Vonoprazan and Amoxicillin for the first 7 days DRUG

20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily for 7 days

Also known as: L-VA-7

14-day Vonoprazan-Amoxicillin dual sequential therapy

Vonoprazan and Amoxicillin for the first 5 days DRUG

20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily for 5 days

Also known as: L-VA-5

10-day Vonoprazan-Amoxicillin dual sequential therapy

Vonoprazan and Amoxicillin for the second 7 days DRUG

20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 7 days

Also known as: H-VA-7

14-day Vonoprazan-Amoxicillin dual sequential therapy

Vonoprazan and Amoxicillin for the second 5 days DRUG

20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 5 days

Also known as: H-VA-5

10-day Vonoprazan-Amoxicillin dual sequential therapy

Vonoprazan and Amoxicillin for 14 days DRUG

20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 14 days

Also known as: VADT-14

14-day Vonoprazan-Amoxicillin dual therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Feng Ye, PhD

CONTACT

86+13815897873; fengye@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 16, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)