Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

NCT ID: NCT05649540

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2024-11-05

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.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

high dose amoxicillin with vonoprazan group

vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days

Group Type: ACTIVE_COMPARATOR

Vonoprazan

Intervention Type: DRUG

Potassium-competitive acid blocker

Amoxicillin

Intervention Type: DRUG

Antibiotic for H. pylori eradication

standard dose amoxicillin with vonoprazan group

vonoprazan 20mg bid and amoxicillin 1000mg bid for 14 days

Group Type: EXPERIMENTAL

Vonoprazan

Intervention Type: DRUG

Potassium-competitive acid blocker

Amoxicillin

Intervention Type: DRUG

Antibiotic for H. pylori eradication

low dose amoxicillin with vonoprazan group

vonoprazan 20mg bid and amoxicillin 500mg tid for 14 days

Group Type: EXPERIMENTAL

Vonoprazan

Intervention Type: DRUG

Potassium-competitive acid blocker

Amoxicillin

Intervention Type: DRUG

Antibiotic for H. pylori eradication

Interventions

Vonoprazan

Potassium-competitive acid blocker

Intervention Type: DRUG

Amoxicillin

Antibiotic for H. pylori eradication

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhenyu Zhang

Director of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhenyu Zhang

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

Changshu No.1 People's Hospital

Changshu, Jiangsu, China

Changzhou Traditional Chinese Medicine Hospital

Changzhou, Jiangsu, China

The first people's hospital of Lianyungang

Lianyungang, Jiangsu, China

Jiangsu Province Hospital on Integration of Chinese and Western Medicine

Nanjing, Jiangsu, China

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Nanjing Jiangbei Hospital

Nanjing, Jiangsu, China

Sir Run Run Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Taixing People's Hospital

Taishing, 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

The Affiliated Zhangjiagang Hospital of Soochow University

Zhangjiagang, Jiangsu, China

Countries

China

References

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Other Identifiers

KY20221124-07

Identifier Type: -

Identifier Source: org_study_id