Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication

Phase 4

Completed

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

• Registration Number: NCT05469685
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

The purpose of this study was to evaluate the Efficacy and Safety of Vonoprazan- amoxicillin dual therapy for Helicobacter Pylori eradication

Detailed Description

This study intends to select the patients with Hp infection in 11 tertiary hospitals across our country, and randomly give the two 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: 2022-07-19
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-22
• Study Start: 2022-08-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-09-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 914

Inclusion Criteria

1. Ages between 18 and 65 years; Sexes eligible for study: both;
2. patients who are diagnosed with Helicobacter pylori;
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10-day treatment group	Vonoprazan	vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days
10-day treatment group	Amoxicillin	vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days
14-day treatment group	Vonoprazan	vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
14-day treatment group	Amoxicillin	vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate	four to six 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
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
Adverse events	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.

Trial Locations

Locations (10)

Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine; 🇨🇳 Nanjing, Jiangsu, China

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

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

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

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

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

Wuxi People's Hospital Affiliated to Nanjing Medical University; 🇨🇳 Wuxi, 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

Yancheng First Hospital,Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Yancheng, Jiangsu, China