Trial intelligence / Profile preview

Vonoprazan Dual Therapy vs Standard Triple Therapy for H. Pylori Eradication

NCT04901663Phase 4

Key facts

Status
Completed
Start
Jun 2021
Primary completion
Aug 2021
Countries
1
Sponsor
Dow University of Health Sciences
Modality
Small Molecules
Conditions
Helicobacter pylori infection
01

Overview

Phase 4, randomised, open-label trial of vonoprazan in Helicobacter pylori infection (2 arms), sponsored by Dow University of Health Sciences. Primary endpoint: Helicobacter Pylori Eradication at 4 weeks. Started Jun 2021; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Omeprazole Group

    Omeprazole 20 mg BD + Amoxicillin 1000 mg BD + Clarithromycin 500 mg BD

  • Vonoprazan Group

    Vonoprazan 20 mg BD + Amoxicillin 1000 mg BD

03

Who it enrols

Patients with confirmed Helicobacter Pylori infection, excluding those with previous stomach surgery, recent antibiotic/PPI/steroid/NSAID use, pregnancy/lactation, substance abuse, or severe neurological/psychiatric disorders.

04

Endpoints

Primary

  • Helicobacter Pylori Eradication

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