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

Optimization of Vonoprazan--amoxicillin Dual Therapy for Eradicating Helicobacter pyloriinfection-a Multicenter, Prospective, Randomized, Parallel-controlled Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05719831
Enrollment
516
Registered
2023-02-09
Start date
2023-02-01
Completion date
2023-09-30
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Eradication Rate

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 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 .

Interventions

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

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

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

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

DRUGvonoprazan fumarate + amoxicillin(H-14d)

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

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
H. pylori eradication rate6 weekRate of h. pylori successfully eradicated;13C-urea breath testthat will be used to assess this outcome measure

Secondary

MeasureTime frameDescription
Adverse Event6 weekRate of adverse event, serious adverse event; Questionnaire that will be used to assess this outcome measure.
Medical financial burden6 weekMedical financial burden;Questionnaire that will be used to assess this outcome measure.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026