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

Helicobacter Pylori Eradication Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05719831
• Other study ID #: HP
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Eradication Rate

Intervention

Drug:
• 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
• vonoprazan fumarate + low dose amoxicillin(L-10d)
vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin1000mg/ time, 2 times/day, oral, for 10d
• vonoprazan fumarate + amoxicillin(H-14d)
vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 14d

Locations

Country	Name	City	State
China	Sixth afflicated of Sun-yat sen university	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H. pylori eradication rate	Rate of h. pylori successfully eradicated;13C-urea breath testthat will be used to assess this outcome measure	6 week
Secondary	Adverse Event	Rate of adverse event, serious adverse event; Questionnaire that will be used to assess this outcome measure.	6 week
Secondary	Medical financial burden	Medical financial burden;Questionnaire that will be used to assess this outcome measure.	6 week