Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy

Fu Jen Catholic University Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Helicobacter Pylori

Treatments: Drug: Extended sequential therapy; Drug: Vonoprazan-based triple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05371249

FJUH110108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 628 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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628 participants in 2 patient groups

Vonoprazan-based triple therapy group

Experimental group

Description:

Including patients receiving vonoprazan-based triple therapy (vonoprazan 20mg + amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days)

Treatment:

Drug: Vonoprazan-based triple therapy

Extended sequential therapy group

Active Comparator group

Description:

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)

Treatment:

Drug: Extended sequential therapy