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14-day Quadruple Therapy Versus Triple Therapy in HP Eradication

NCT04769583 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2021-02-24

No results posted yet for this study

Summary

In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.

Conditions

  • Gastritis H Pylori

Interventions

DRUG

metronidazole based quadriple therapy

patient randomized in QC will be treated by a double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day)

DRUG

placebo based quadriple therapy

patient randomized in TT will be treated by double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), clarithromycin (500 mg x 2 per day) and a placebo of metronidazole.

Sponsors & Collaborators

  • mohamed bouchoucha

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-10
Primary Completion
2020-02-17
Completion
2020-03-05

Countries

  • Tunisia

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 NCT04769583 on ClinicalTrials.gov