Efficacy of Vonoprazan based dual therapy with amoxicillin versus standard triple therapy for Helicobacter pylori eradication in Thailand

Phase 4

Completed

• Conditions: Helicobacter pylori; vonoprazan; Efficacy of the 7-day vonoprazan and amoxicillin dual therapy for H. pylori treatment and compared it with standard triple therapy

• Registration Number: TCTR20210216003
• Lead Sponsor: Gastroenterological association of Thailand

Brief Summary

7-days VA-dual regimen is non-inferiority than 14-days OAC-triple regimen as a first-line H. pylori eradication therapy and incidence of adverse events was a trend to lower in VA-dual subjects.

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-01-31
• Study Start: 2021-02-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1) subjects undergoing gastrointestinal endoscopy at Department of Gastroenterology Phramongkutklao Hospital during 1 August 2019 to 28 February 2020
2) aged 18 years or over
3) diagnosis of H.pylori infection using upper GI endoscopy with the rapid urease test and positive test result of the infection.

Exclusion Criteria

1) GFR <30 ml/min/1.73m2
2) history of drug resistance used in research studies
3) pregnant women or breastfeeding mothers
4) History treatment of H.pylori infection
5) Subjects in critical condition
6) Subjects to be diagnosed with neuroendocrine tumor, HIV infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eradication rate 6 wks Remission rate after treatment

Secondary Outcome Measures

Name	Time	Method
Side effect 6 wks Questionare