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Standard Triple Therapy vs Sequential Therapy in Treatment of H Pylori Infection

NCT01723059 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2012-11-07

No results posted yet for this study

Summary

Traditionally, H pylori infection has been treated with conventional triple therapy. This includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14 days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe will not be predictive of resistance patterns and response rates in the United States.

Conditions

  • Helicobacter Infection

Interventions

DRUG

Standard Triple Therapy

for 10 days

DRUG

Sequential Therapy

total 10 days

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    collaborator INDUSTRY

  • Dallas VA Medical Center

    lead FED

Principal Investigators

  • Byron Cryer, MD · Gastroenterologist, MD VA

  • Robert Genta, MD · Pathologist, MD

  • Elizabeth Coss, MD · Gastroenterology Fellow, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

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 NCT01723059 on ClinicalTrials.gov