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Completed

NCT Number: NCT01760824

Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication

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.

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Key information

Age range

18 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

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 HP may develop peptic ulcers. However, failure rate is rising due to multiple resistant HP infection. The eradication rate of first line clarithromycin based therapy has fell to below 80% and increasing number of patients also failed the second line quadruple therapy. 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.

Methods: Eligible H. pylori positive patients were randomized to receive either QUAD (esomeprazole 20mg twice daily, bismuth subcitrate 120mg four times daily, tetracycline 500mg four times daily and metronidazole 400mg four times daily) for 10 days or SEQ (esomeprazole 20mg twice daily for 10 days, amoxicillin 1g twice daily for first 5 days, clarithromycin 500mg twice daily and metronidazole 400mg four time daily for the subsequent 5 days). All patients returned 8 weeks after completing the treatment for a Urea Breath Test (UBT) to confirm eradication. Patients who failed their respective therapy were crossover to receive the alternative regimen.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with age 18 or above, diagnosed to have gastric HP infection

Exclusion criteria

  • Patients with age less than 18, with past allergy to the study medications, concurrent critical illnesses, a history of previous upper gastrointestinal surgery, intake of nonsteroidal anti-inflammatory drugs, antibiotics, probiotics, bismuth preparation, proton pump inhibitors, anticoagulants or steroids in the previous one month, pregnant or breast-feeding women, drug abusers or alcoholic, history of previous H. Pylori treatment

Treatment and study plan

sequential therapy

Drug

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

Other names: Esomeprazole (Nexium) 20mg bid for 10 days, Amoxicillin 1g bid for first 5 days, Clarithromycin (Klacid) 500mg bid for last 5 days, Metronidazole (Flagyl) 400mg qid for last 5 days

Quadruple therapy

Drug

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

Other names: Esomeprazole (Nexium) 20mg bid, Metronidazole (Flagyl) 400mg qid, Bismuth subcitrate 120mg qid, Tetracycline 500mg qid, all for 10 days

Primary outcomes

  1. Helicobacter pylori eradication rate

    Time frame: 8 weeks after treatment

    Percentage of patients successfully eradicated Helicobacter pylori infection confirmed by urea breath test

Secondary outcomes

  1. Development of side effects

    Time frame: 10 days

    Patients to document side effects during treatment

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Ten Days Quadruple Versus Sequential Therapy as Empirical First and Second Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 4, 2013
Registry last updated
Jan 4, 2013

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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