Vonoprazan Fumarate in Combination With Amoxicillin for the First-line Eradication of Helicobacter Pylori -- a Multicenter, Randomized, Parallel Controlled Study

NCT ID: NCT05196945

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2023-02-28

Brief Summary

Helicobacter pylori infection is closely related to gastritis, peptic ulcer, mucosa-associated lymphoid tissue lymphoma and gastric cancer. Eradication of HP can significantly improve and reduce HP-related diseases. International and domestic guidelines recommend a 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 80%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. Studies at home and abroad have shown that high-dose proton pump inhibitors combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. And because it is a single antibiotic therapy, we do not expect this regimen to increase antibiotic resistance rates for HP. The maintenance of gastric PH > 6 is one of the key factors for HP eradication. The acid inhibition effect of proton pump mainly depends on the degree of individual metabolism of proton pump. Vonoprazan fumarate, a new competitive potassium acid blocker, is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with proton pump inhibitors. In most parts of China, HP is characterized by high infection rate and antibiotic resistance rate, requiring higher eradication rate and safety regimen. This study compared the efficacy and safety of vonoprazan fumarate combined with amoxicillin and bismuth-containing quadruple regimen in first-line HP eradication, in order to find a more suitable regimen for HP eradication.

Conditions

Helicobacter Pylori Eradication Rate

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VA-dual

14 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral

+Amoxicillin 750mg/ time, 4 times/day, oral)

Group Type: EXPERIMENTAL

vonoprazan fumarate + amoxicillin

Intervention Type: DRUG

vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral

EACP - quadruple

14days(Esomeprazole 20mg/ time, 2 times/day, oral+Amoxicillin 1g/ time, 2 times/day, oral+Clarithromycin 0.5g/ time, 2 times/day, oral+Bismuth potassium citrate 220mg/ time, twice a day, orally)

Group Type: ACTIVE_COMPARATOR

Esomeprazole +Amoxicillin+Clarithromycin+Bismuth potassium citrate

Intervention Type: DRUG

Esomeprazole 20mg/ time, 2 times/day, oral Amoxicillin 1g/ time, 2 times/day, oral Clarithromycin 0.5g/ time, 2 times/day, oral Bismuth potassium citrate 220mg/ time, twice a day, orally

Interventions

vonoprazan fumarate + amoxicillin

vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral

Intervention Type: DRUG

Esomeprazole +Amoxicillin+Clarithromycin+Bismuth potassium citrate

Esomeprazole 20mg/ time, 2 times/day, oral Amoxicillin 1g/ time, 2 times/day, oral Clarithromycin 0.5g/ time, 2 times/day, oral Bismuth potassium citrate 220mg/ time, twice a day, orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Age 18-70, regardless of gender; HP positive in 13C/14C breath test or pathological test; HP eradication has never been performed in the past; Based on the consensus of helicobacter pylori in 2017, it conforms to the HP eradication guideline; The patient voluntarily signed the informed consent.

Exclusion Criteria

History of drug allergy in this study; Liver and kidney dysfunction; Cardiopulmonary insufficiency; History of malignant tumor; Taking clopidogrel, warfarin and other drugs simultaneously may affect CYP2C19 metabolism; Pregnant or lactating women; Patients with severe mental illness; Those planning pregnancy; Previous upper gastrointestinal surgery history; Participated in any other clinical investigator in the last 3 months.

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

Sponsors

Zhejiang University

OTHER

Sponsor Role: collaborator

People's Hospital of Chongqing

OTHER

Sponsor Role: collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

Shengjing Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Southern Medical University, China

OTHER

Sponsor Role: collaborator

First People's Hospital of Foshan

OTHER

Sponsor Role: collaborator

Guangzhou Panyu Central Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Shantou University Medical College

OTHER

Sponsor Role: collaborator

The Seventh Affiliated Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

pengxiang

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2022ZSLYEC-003

Identifier Type: -

Identifier Source: org_study_id