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Completed

NCT Number: NCT01085786

Sequential and Hybrid Therapies for H Pylori Infection

Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

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About this study

The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate equal to or more than 95%.

A total of 240 subjects will be asked to participate in this study.

H. pylori-infected patients are randomized to either a 14-day sequential therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days).

Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H. pylori therapy. The eradication rates of the two study groups will be compared.

A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95%.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • consecutive H. pylori-infected outpatients, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion criteria

  • previous H. pylori-eradication therapy
  • ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
  • patients with allergic history to the medications used
  • patients with previous gastric surgery
  • the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
  • pregnant women.

Treatment and study plan

14-day sequential treatment

Drug
  • 14-day sequential therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
  • 14-day hybrid therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days

Other names: Esomeprazole, amoxicillin, clarithromycin, metronidazole

14-day hybrid treatment

Drug

esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days

Other names: esomeprazole + amoxicillin, then quadruple therapy

Primary outcomes

  1. Number of Participants in Which H. Pylori Was Eradicated

    Time frame: Dec 2010

    evaluate eradication outcome by endoscopy with urease test or urea breath test

Secondary outcomes

  1. Adverse Events

    Time frame: Dec 2010

    by standardized questionnaire

  2. Compliance Rate

    Time frame: Dec 2010

    Good compliance is defined as taking equal or more than 90% of eradication medicines

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Collaborators

  • Baylor College of Medicine
  • Kaohsiung Medical University

Registry information

Official study title

Comparison of 14-day Sequential and Hybrid Therapies for H Pylori Infection

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 12, 2010
Registry last updated
Sep 21, 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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