Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy

Seven-Day Vonoprazan-Based Triple Therapy With High-Dose Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial in Taiwan

This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.

Study Overview

• Status: Active, not recruiting
• Conditions: Helicobacter Pylori
• Intervention / Treatment: Drug: Vonoprazan-based triple therapy; Drug: Extended sequential therapy

Detailed Description

Helicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Extended proton pump inhibitor (PPI)-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 90.7% (95% CI, 87.4% - 94.0%). Nevertheless, its complexity of the "sequential" usage is sometimes confusing to the patients and may lead to treatment failure. The emerging new regimen - vonoprazan-based triple therapy, on the other hand, is another appealing choice with simplicity, short treatment duration, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based triple therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based triple therapy with high-dose Amoxicillin.

• Study Type: Interventional
• Enrollment (Actual): 628
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yu-tse Chiu, MD; Phone Number: +886912410603; Email: b95401030@gmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 243
    • Fu Jen Catholic University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited.

Exclusion Criteria:

• Who had received helicobacter pylori eradication before
• Who are known to be allergic to any drug used in this trial
• Pregnant women
• Who are refuse to participate in the trial for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vonoprazan-based triple therapy group; Including patients receiving vonoprazan-based triple therapy (vonoprazan 20mg + amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days)	Drug: Vonoprazan-based triple therapy; vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days; Other Names: VAC-7
Active Comparator: Extended sequential therapy group; Including patients receiving extended sequential therapy (lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days)	Drug: Extended sequential therapy; Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days; Other Names: S-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate of helicobacter pylori	Assessed by urea breath test	Assessed at least 6 weeks after the therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects of the drugs	Self-reported adverse effects by patients through a questionnaire.	After patients completed the therapy (For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)
Compliance	Self-reported compliance by patients through a questionnaire.	After patients completed the therapy ((For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University Hospital
• Investigators: Study Chair: Yu-tse Chiu, MD, Fu Jen Catholic University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: May 8, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Proton Pump Inhibitors
• Other Study ID Numbers: FJUH110108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository and are available on request for the use of academic research in relevant field after the study is published, in the form of excel file with de-identification (main contact: Chiu, Yu-tse, b95401030@gmail.com; consent from participants had been obtained).
• IPD Sharing Time Frame: IPD will be available on request for the use of academic research in relevant field after the study is published.
• IPD Sharing Access Criteria: The purpose of obtaining the IPD should be for the use of academic research in relevant field.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No