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

Primary Purpose

Vonoprazan, Helicobacter Pylori Infection, Proton Pump Inhibitor

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vonoprazan Tablets
Amoxicillin Capsules
Esomeprazole
Sponsored by
First People's Hospital of Hangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vonoprazan focused on measuring vonoprazan, Helicobacter Pylori, Proton pump inhibitor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hangzhou first people's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vonoprazan 20mg QD

esomeprazole 20 mg BID

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at 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.

Secondary Outcome Measures

Full Information

First Posted
October 19, 2022
Last Updated
November 23, 2022
Sponsor
First People's Hospital of Hangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT05590286
Brief Title
A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection
Acronym
VATH-1
Official Title
A RCT of the Efficacy of Vonoprazan 20mg QD Combined With Amoxicillin 750mg QID in the Treatment of Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Hangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vonoprazan, Helicobacter Pylori Infection, Proton Pump Inhibitor
Keywords
vonoprazan, Helicobacter Pylori, Proton pump inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vonoprazan 20mg QD
Arm Type
Experimental
Arm Description
Vonoprazan 20 mg, tablets, orally, qd given in combination with amoxicillin 750mg capsules, orally, qid for up to 2 weeks.
Arm Title
esomeprazole 20 mg BID
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vonoprazan Tablets
Intervention Description
Vonoprazan 20 mg, tablets, orally，QD
Intervention Type
Drug
Intervention Name(s)
Amoxicillin Capsules
Intervention Description
Amoxicillin 750mg, Capsules ,orally，QID
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Esomeprazole 20mg, Capsules ,orally，BID
Primary Outcome Measure Information:
Title
Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment
Description
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.
Time Frame
Week 4 post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongzhang Shen
Phone
057156005600
Email
sakshen@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofeng Zhang
Phone
057156005600
Facility Information:
Facility Name
Hangzhou first people's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zhang, Bachelor
Phone
0086057156006782
Email
837837@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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