Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy

Phase 4

Active, not recruiting

• Conditions: Helicobacter Pylori
• Interventions: Drug: Vonoprazan-based triple therapy; Drug: Extended sequential therapy

• Registration Number: NCT05371249
• Lead Sponsor: Fu Jen Catholic University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-04-24
• Study First Submitted QC: 2022-05-08
• Study First Posted: 2022-05-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07
• Primary Completion: 2023-12-30
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 628

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vonoprazan-based triple therapy group	Vonoprazan-based triple therapy	Including patients receiving vonoprazan-based triple therapy (vonoprazan 20mg + amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days)
Extended sequential therapy group	Extended sequential therapy	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)

Primary Outcome Measures

Name	Time	Method
Eradication rate of helicobacter pylori	Assessed at least 6 weeks after the therapy	Assessed by urea breath test

Secondary Outcome Measures

Name	Time	Method
Adverse effects of the drugs	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.
Compliance	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.

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital; 🇨🇳 New Taipei City, Taiwan