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Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management

NCT05614934 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-02-21

No results posted yet for this study

Summary

Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens.

The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

standard Clarithromycin triple therapy

Oral administration of proton pump inhibitor standard or double dose twice daily, clarithromycin 500 mg twice daily and, Amoxicillin1g twice daily for 14 days

DRUG

Vonoprazan triple therapy

Oral administration of Vonoprazan 20mg twice daily, clarithromycin 500 mg twice daily, and, Amoxicillin1g twice daily for 14 days

DRUG

Vonoprazan dual therapy

Oral administration of Vonoprazan 20mg twice daily and, Amoxicillin1g three times daily for 14 days

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-11
Primary Completion
2023-05-01
Completion
2023-05-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05614934 on ClinicalTrials.gov