Trial intelligence / Profile preview

Triple vs Sequential vs Concomitant Therapy for H. pylori

NCT02092506Phase 4

Key facts

Status
Completed
Start
Dec 2011
Primary completion
Jun 2014
Countries
1
Sponsor
Changi General Hospital
Modality
Small Molecules
Conditions
Helicobacter pylori infection
01

Overview

Phase 4, randomised, open-label trial of amoxicillin, clarithromycin and metronidazole in Helicobacter pylori infection (3 arms), sponsored by Changi General Hospital. Primary endpoint: H. pylori eradication rate. Started Dec 2011; status: completed.

02

Design

3 arms
Study design
RandomizedOpen-label
  • Triple Therapy

    PPI + Amoxicillin + Clarithromycin for 10 days

  • Sequential Therapy

    PPI + Amoxicillin (5 days) -> PPI + Clarithromycin + Metronidazole (5 days)

  • Concomitant Therapy

    PPI + Amoxicillin + Clarithromycin + Metronidazole for 10 days

03

Who it enrols

Consecutive patients newly diagnosed with H. pylori infection, excluding those with known allergies or previous therapy.

04

Endpoints

Primary

  • H. pylori eradication rate

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