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Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication

NCT01760824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2013-01-04

No results posted yet for this study

Summary

Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection. The eradication rate of first line clarithromycin based therapy has fallen to below 80%. Both quadruple and sequential treatment regime has been proposed as the first-line empirical regime. Nevertheless, comparison in terms of efficacy and side effects between the two regime remained unknown. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Sequential therapy

Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days

DRUG

Quadruple therapy

Esomeprazole 20mg bid, metronidazole 400mg qid, bismuth sub citrate 120mg qid and tetracycline 500mg qid, all for 10 days

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Ivan FN Hung, MD FRCP · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • Hong Kong

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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 NCT01760824 on ClinicalTrials.gov