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Completed

NCT Number: NCT01306786

Five Days Quadruple and Clarithromycin Containing Triple Therapy as Treatment for Helicobacter Pylori Eradication

The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori eradication with a 5-day quadruple therapy versus a clarithromycin-containing triple therapy.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong, Queen Mary Hospital

Hong Kong SAR, Hong Kong

About this study

Eligible patients with H pylori infection were randomized to receive either five-day QUAD (esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.) or EAC (esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d.). H. pylori status was rechecked by 13C urea breath test 8 weeks after treatment. Patients who failed their respective therapy were invited to undergo H. pylori susceptibility testing and crossover to receive the alternative regimen for the same duration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with H. pylori infection
  • did not receive H. pylori eradication therapy before

Exclusion criteria

  • patients who have received previous H. pylori eradication therapy
  • co-morbidity of liver cirrhosis
  • co-morbidity of renal failure
  • co-morbidity of alcoholism
  • co-morbidity of malignancy
  • received antibiotics, bismuth preparations, proton pump inhibitors or probiotic in the preceding three months
  • patients with known allergy to the medications used
  • patients with a history of previous gastrointestinal diseases or gastric surgery
  • pregnancy

Treatment and study plan

Quadruple therapy

Drug

First line: 5 days esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.

Cross over second line for those who failed first line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d

triple therapy

Drug

First line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d Second line cross over if failed first line: 7 days quadruple therapy: esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.)

Primary outcomes

  1. H pylori eradication

    Time frame: 8 weeks after treatment

    Successful H pylori eradication documented by urea breath test after first and second line treatments. Cross over if patients failed first line treatment

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 10 weeks outpatient follow-up

    Assessed adverse effects and compliance by standard questionnaire upon 10 weeks outpatient follow-up

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Five Days Quadruple and Clarithromycin Containing Triple Therapy as Empirical First and Second-Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Mar 2, 2011
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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