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Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection

NCT00656968 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2015-09-30

Study results available
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Summary

Helicobacter pylori is a bacteria that infects the lining of the stomach and is associated with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain forms of gastric cancer. Curing this infection generally requires that patients take 2 or more antibiotic medications and a stomach acid suppressing medication for about two weeks. Current treatments do not always cure the infection and a new treatment is being tested in this study. The drugs involved in the new 4 drug treatment have been widely used for treatment of this infection. It remains unknown what is the best and most cost effective way to give them. This study will compare three different ways of using these drugs.

Subjects must have active Helicobacter pylori infection in order to participate in this study.

Conditions

  • Helicobacter Infection

Interventions

DRUG

10-day sequential treatment

esomeprazole (40 mg daily) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, metronidazole (500 mg, bid) from day 6 to day 10

DRUG

10-day concomitant therapy

esomeprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 10, clarithromycin (500 mg, bid) from day 1 to day 10, metronidazole (500 mg, bid) from day 1 to day 10

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • Kaohsiung Veterans General Hospital.

    lead OTHER

Principal Investigators

  • Ching-Kuan Liu, MD, PhD · Kaohsiung Medical Univestity

  • David Y Graham, MD · Baylor College of Medicine

  • Antone R Opekun, PA-C · Baylor College of Medicine

  • Deng-Chyang Wu, MD PhD · Kaohsiung Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-06-30
Completion
2010-06-30

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 NCT00656968 on ClinicalTrials.gov