VATH-1: A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection

Sponsor

First People's Hospital of Hangzhou (Other)

Overall Status

Recruiting

CT.gov ID

NCT05590286

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vonoprazan Helicobacter Pylori Infection Proton Pump Inhibitor	Drug: Vonoprazan Tablets Drug: Amoxicillin Capsules Drug: Esomeprazole	Phase 4

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A RCT of the Efficacy of Vonoprazan 20mg QD Combined With Amoxicillin 750mg QID in the Treatment of Helicobacter Pylori Infection

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vonoprazan 20mg QD Vonoprazan 20 mg, tablets, orally, qd given in combination with amoxicillin 750mg capsules, orally, qid for up to 2 weeks.	Drug: Vonoprazan Tablets Vonoprazan 20 mg, tablets, orally，QD Drug: Amoxicillin Capsules Amoxicillin 750mg, Capsules ,orally，QID
Active Comparator: 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.	Drug: Amoxicillin Capsules Amoxicillin 750mg, Capsules ,orally，QID Drug: Esomeprazole Esomeprazole 20mg, Capsules ,orally，BID

Arm

Intervention/Treatment

Experimental: vonoprazan 20mg QD

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

Drug: Vonoprazan Tablets

Vonoprazan 20 mg, tablets, orally，QD

Drug: Amoxicillin Capsules

Amoxicillin 750mg, Capsules ,orally，QID

Active Comparator: 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.

Drug: Amoxicillin Capsules

Amoxicillin 750mg, Capsules ,orally，QID

Drug: Esomeprazole

Esomeprazole 20mg, Capsules ,orally，BID

Outcome Measures

Primary Outcome Measures

Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment [Week 4 post-treatment]
HP infection status will be determined by ^13C Urea Breath Test (^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

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.