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

Helicobacter Pylori Eradication Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05196945
• Other study ID #: 2022ZSLYEC-003
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 31, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2022
• 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 316
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• 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 + amoxicillin
vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral
• 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

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor

Collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

First Affiliated Hospital of Shantou University Medical College, First People's Hospital of Foshan, General Hospital of Tianjin Medical University, Guangzhou Panyu Central Hospital, Nanhai Hospital, Southern Medical University, People's Hospital of Chongqing, Shengjing Hospital, Shunde Hospital of Southern Medical University, The Second Affiliated Hospital of Dalian Medical University, Zhejiang University

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