Optimization of Vonoprazan--amoxicillin Dual Therapy for Eradicating Helicobacter Pyloriinfection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 aimed to evaluate two different amoxicillin dosages

(1 g b.i.d. vs. 0.75 g q.i.d.) and two different durations of therapy (14 vs.10 days) to gain insights of the effectiveness of VA dual therapy .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05196945

Helicobacter Pylori Eradication Rate

UNKNOWN PHASE4

Helicobacter Pylori and Vonoprazan Dual Therapy

NCT05649709

Helicobacter Pylori

COMPLETED PHASE4

Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

NCT05649540

Helicobacter Pylori Infection

COMPLETED PHASE4

Comparison of Vonoprazan-based Versus Lansoprazole-based Triple Therapy, High Dose Dual Therapy, Bismuth and Non-bismuth Quadruple Therapy in the First-line Treatment of Helicobacter Pylori Infection

NCT04713670

H. Pylori Infection

RECRUITING PHASE4

The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori

NCT05189444

Helicobacter Pylori Infection

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Helicobacter Pylori Eradication Rate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

H-VA-dual-10

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

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

Group Type EXPERIMENTAL

vonoprazan fumarate + high dose amoxicillin（H-10d）

Intervention Type DRUG

vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 10d

L-VA-dual-10

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

+Amoxicillin 1000mg/ time, 2 times/day, oral)

Group Type EXPERIMENTAL

vonoprazan fumarate + low dose amoxicillin（L-10d)

Intervention Type DRUG

vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin1000mg/ time, 2 times/day, oral, for 10d

H-VA-dual-14

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

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

Group Type ACTIVE_COMPARATOR

vonoprazan fumarate + amoxicillin（H-14d)

Intervention Type DRUG

vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 14d

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vonoprazan fumarate + high dose amoxicillin（H-10d）

vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 10d

Intervention Type DRUG

vonoprazan fumarate + low dose amoxicillin（L-10d)

vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin1000mg/ time, 2 times/day, oral, for 10d

Intervention Type DRUG

vonoprazan fumarate + amoxicillin（H-14d)

vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 14d

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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