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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05196945
Enrollment
316
Registered
2022-01-19
Start date
2022-03-31
Completion date
2023-02-28
Last updated
2022-02-17

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 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.

Interventions

DRUGvonoprazan fumarate + amoxicillin

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

DRUGEsomeprazole +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

Sponsors

Zhejiang University
CollaboratorOTHER
People's Hospital of Chongqing
CollaboratorOTHER
Tianjin Medical University General Hospital
CollaboratorOTHER
Shengjing Hospital
CollaboratorOTHER
The Second Affiliated Hospital of Dalian Medical University
CollaboratorOTHER
Southern Medical University, China
CollaboratorOTHER
First People's Hospital of Foshan
CollaboratorOTHER
Guangzhou Panyu Central Hospital
CollaboratorOTHER
First Affiliated Hospital of Shantou University Medical College
CollaboratorOTHER
The Seventh Affiliated Hospital, Southern Medical University
CollaboratorOTHER
Sixth Affiliated Hospital, Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026