Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

628 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Helicobacter Pylori

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Vonoprazan-based triple therapy

Intervention Type DRUG

vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days

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)

Group Type ACTIVE_COMPARATOR

Extended sequential therapy

Intervention Type DRUG

Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days

Interventions

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