Skip to main content
OpenTrials
Completed

NCT Number: NCT05371249

Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fu Jen Catholic University Hospital

New Taipei City, 243, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vonoprazan-based triple therapy

Drug

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

Other names: VAC-7

Extended sequential therapy

Drug

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

Primary outcomes

  1. Eradication rate of helicobacter pylori

    Time frame: Assessed at least 6 weeks after the therapy

    Assessed by urea breath test

Secondary outcomes

  1. Adverse effects of the drugs

    Time frame: After patients completed the therapy (For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)

    Self-reported adverse effects by patients through a questionnaire.

  2. Compliance

    Time frame: After patients completed the therapy ((For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)

    Self-reported compliance by patients through a questionnaire.

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
May 12, 2022
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.