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Sequential and Hybrid Therapies for H Pylori Infection

NCT01085786 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-09-21

Study results available
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Summary

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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

14-day sequential treatment

* 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

DRUG

14-day hybrid treatment

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

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • Kaohsiung Medical University

    collaborator OTHER

  • Kaohsiung Veterans General Hospital.

    lead OTHER

Principal Investigators

  • Kwok-Hung Lai, PhD · Kaohsiung Veterans General Hospital.

  • David Y Graham, MD · Baylor College of Medicine

  • PING-I Hsu, MD, PhD · Kaohsiung Veterans General Hospital.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Taiwan

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 NCT01085786 on ClinicalTrials.gov