Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

Phase 4

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Vonoprazan; Drug: Amoxicillin

• Registration Number: NCT05649540
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.

Detailed Description

This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection.

Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.

Study Timeline

• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-14
• Study Start: 2023-01-20
• Primary Completion: 2024-07-06
• Status Verified: 2024-11
• Study Completion: 2024-11-05
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. Ages between 18 and 70 years; Sexes eligible for study: both;
2. patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test;
3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
4. voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion Criteria

1. allergic reactions to the study drugs;
2. patients with peptic ulcer;
3. patients who underwent eradication therapy for Helicobacter pylori during the last six months;
4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
6. patients who have history of esophageal or gastric surgery;
7. pregnant or lactating women;
8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
9. Alcohol abusers
10. MALT lymphoma of stomach or malignant tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard dose amoxicillin with vonoprazan group	Amoxicillin	vonoprazan 20mg bid and amoxicillin 1000mg bid for 14 days
high dose amoxicillin with vonoprazan group	Vonoprazan	vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
standard dose amoxicillin with vonoprazan group	Vonoprazan	vonoprazan 20mg bid and amoxicillin 1000mg bid for 14 days
high dose amoxicillin with vonoprazan group	Amoxicillin	vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
low dose amoxicillin with vonoprazan group	Vonoprazan	vonoprazan 20mg bid and amoxicillin 500mg tid for 14 days
low dose amoxicillin with vonoprazan group	Amoxicillin	vonoprazan 20mg bid and amoxicillin 500mg tid for 14 days

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate	four to eight weeks after completion of the medication	Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.

Secondary Outcome Measures

Name	Time	Method
Microbiota influence	baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy	Collect the tongue coating and feces of some patients for flora analysis
Adverse event	Within 7 days after completion of therapy	Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy.
Compliance Rate	Within 7 days after completion of therapy	Compliance was defined as poor when they had taken less than 80% of the total medication

Trial Locations

Locations (13)

Changzhou Traditional Chinese Medicine Hospital; 🇨🇳 Changzhou, Jiangsu, China

Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

The Affiliated Zhangjiagang Hospital of Soochow University; 🇨🇳 Zhangjiagang, Jiangsu, China

Changshu No.1 People's Hospital; 🇨🇳 Changshu, Jiangsu, China

The first people's hospital of Lianyungang; 🇨🇳 Lianyungang, Jiangsu, China

Nanjing Jiangbei Hospital; 🇨🇳 Nanjing, Jiangsu, China

Jiangsu Province Hospital on Integration of Chinese and Western Medicine; 🇨🇳 Nanjing, Jiangsu, China

Nanjing First Hospital, Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

Sir Run Run Hospital, Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

Taixing People's Hospital; 🇨🇳 Taixing, Jiangsu, China

The Fourth People's Hospital of Taizhou; 🇨🇳 Taizhou, Jiangsu, China

The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China

Affiliated Hospital of Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China