Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy

Phase 4 Completed 628 enrolled Fu Jen Catholic University Hospital

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2021-12-01
Primary completion: 2023-12-30
Completion: 2024-02-28

Outcome

Met primary endpoint

paper The VAC-7 was non-inferior to S-14 in terms of ITT analysis. PMID 39164808 ↗

Publications

Chiu YT, Lee FJ, Kuo CY, Chen YT, Lin YC, Liang KS, Wu CY, Lin RT, Lin JT, Chang CY. Seven-Day Vonoprazan-Based Triple Therapy as First-Line Helicobacter pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13129. doi: 10.1111/hel.13129.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clarithromycin	Small molecule	500 mg	—
Comparator	Lansoprazole	Other / unclassified	30 mg	—
Comparator	Metronidazole	Small molecule	500 mg	—
Subject	Vonoprazan	Other / unclassified	20 mg	—
Background	Amoxicillin	Other / unclassified	1000 mg	—