A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection

NCT ID: NCT05590286

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-12-31

Brief Summary

The treatment of helicobacter pylori is very important. The routine treatment is quadruple therapy. In recent years, double therapy has appeared and the curative effect is fair. However, antacid generally uses proton pump inhibitor. The proton pump inhibitor needs double dose to achieve good antacid curative effect. The effect of vonoprazan used for inhibiting gastric acid is better than proton pump inhibitor. At present, many studies use vonoprazan instead of common proton pump inhibitor, but almost all use double dose of vonoprazan. In the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 20mg QD of vonoprazan. Therefore, in this study, 20mg QD of vonoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of vonoprazan on Helicobacter pylori.

Detailed Description

The treatment of helicobacter pylori is very important. The routine treatment is quadruple therapy. In recent years, double therapy has appeared and the curative effect is fair. However, antacid generally uses proton pump inhibitor. The proton pump inhibitor needs double dose to achieve good antacid curative effect. The effect of vonoprazan used for inhibiting gastric acid is better than proton pump inhibitor. At present, many studies use vonoprazan instead of common proton pump inhibitor, but almost all use double dose of vonoprazan. In the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 20mg QD of vonoprazan. Therefore, in this study, 20mg QD of vonoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of vonoprazan on Helicobacter pylori.

Conditions

Vonoprazan; Helicobacter Pylori Infection; Proton Pump Inhibitor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vonoprazan 20mg QD

Vonoprazan 20 mg, tablets, orally, qd given in combination with amoxicillin 750mg capsules, orally, qid for up to 2 weeks.

Group Type: EXPERIMENTAL

Vonoprazan Tablets

Intervention Type: DRUG

Vonoprazan 20 mg, tablets, orally，QD

Amoxicillin Capsules

Intervention Type: DRUG

Amoxicillin 750mg, Capsules ,orally，QID

esomeprazole 20 mg BID

esomeprazole 20 mg, tablets, orally, bid given in combination with amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks.

OR esomeprazole 20 mg, tablets, orally, bis in die given in combination with amoxicillin 750mg capsules, orally, quarter die for up to 2 weeks.

Group Type: ACTIVE_COMPARATOR

Amoxicillin Capsules

Intervention Type: DRUG

Amoxicillin 750mg, Capsules ,orally，QID

Esomeprazole

Intervention Type: DRUG

Esomeprazole 20mg, Capsules ,orally，BID

Interventions

Vonoprazan Tablets

Vonoprazan 20 mg, tablets, orally，QD

Intervention Type: DRUG

Amoxicillin Capsules

Amoxicillin 750mg, Capsules ,orally，QID

Intervention Type: DRUG

Esomeprazole

Esomeprazole 20mg, Capsules ,orally，BID

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients aged ≥18 years with Hp-positive first sterilization were included in this study. Before treatment, the existence of Helicobacter pylori can be confirmed by one or more of the following methods: rapid urease test, Hp culture, 13C urea breath test, 14C urea breath test and stool Hp antigen test.

Exclusion Criteria

The main exclusion criteria include acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric or duodenal mucosal lesions, previous eradication treatment of Helicobacter pylori, penicillin/furazolidone allergy, surgery that may affect gastric acid secretion (upper gastrointestinal resection or vagotomy), Zollinger-Ellison syndrome or other hypergastric acid secretion diseases, severe neurological, cardiovascular, pulmonary, liver, renal, metabolic, gastrointestinal, urological, etc. Any fertile woman must use proper contraception. All subjects provided written informed consent before participating in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

ZhangXiaofeng

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hangzhou first people's Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongzhang Shen

Role: CONTACT

sakshen@126.com

057156005600

Xiaofeng Zhang

Role: CONTACT

057156005600

Facility Contacts

Xiaofeng Zhang, Bachelor

Role: primary

837837@zju.edu.cn

0086057156006782

Other Identifiers

2022-183

Identifier Type: -

Identifier Source: org_study_id