Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy

Helicobacter Pylori Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05371249
• Other study ID #: FJUH110108
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 1, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: August 2023
• Source: Fu Jen Catholic University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 628
• Est. completion date: February 28, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori

Intervention

Drug:
• Vonoprazan-based triple therapy
vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days
• 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

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate of helicobacter pylori	Assessed by urea breath test	Assessed at least 6 weeks after the therapy
Secondary	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)
Secondary	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)