Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy

January 30, 2015 updated by: National Taiwan University Hospital

Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection- A Multi-center Randomized Trial

To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy

Study Overview

Detailed Description

About 600 patients who failed from first line triple therapy or sequential therapy will be eligible in this multicenter randomized comparative trial. Eligible patients will be randomized to receive either (1) levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕or (2) levofloxacin-based triple therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)〕. Eradication will be confirmed with 13C-Urea Breath Test 6 weeks after therapy.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Hsinchu, Taiwan
        • Recruiting
        • National Taiwan University Hospital, Hsinchu Branch
        • Contact:
          • Wen-Fong Hsu
      • Kaohsiung, Taiwan
        • Recruiting
        • E-DA Hospital and I-Shou University
        • Contact:
          • Chi-yang Chang
      • Kaohsiung, Taiwan
        • Recruiting
        • Kaohsiung Medical University
        • Contact:
          • Jeng-Yih Wu
      • Lienchiang, Taiwan
        • Recruiting
        • Health Bureau of Lienchiang County
        • Contact:
          • Feng-Yun Tsao
      • Taipei, Taiwan
        • Recruiting
        • Taipei Medical University Hospital
        • Contact:
          • Chun-Chao Chang
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taiwan
        • Recruiting
        • Mackay Memorial Hospital
        • Contact:
          • Wen-Hsiung Chang
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veteran General Hospital
        • Contact:
          • Jing-Chuan Luo
      • Taitung Branch, Taiwan
        • Recruiting
        • Mackay Memorial Hospital
        • Contact:
          • Ming-Jong Bair
      • Yunlin, Taiwan
        • Recruiting
        • National Taiwan University Hospital , Yunlin
        • Contact:
          • Chieh-Chang Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • H. pylori infected patients who failed from first line therapy will be eligible in this study

Exclusion Criteria:

  • Patients were excluded from the study if any one of the following criteria was present:
  • children and teenagers aged less than 20 years,
  • history of gastrectomy,
  • gastric malignancy, including adenocarcinoma and lymphoma,
  • previous allergic reaction to antibiotics (amoxicillin, metronidazole, levofloxacin) and PPI (lansoprazole),
  • contraindication to treatment drugs,
  • pregnant or lactating women, or
  • severe concurrent disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: levofloxacin-based sequential therapy
levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕
Other Names:
  • Takepron
  • Cravit
  • Flagyl
  • Amoxicillin
Active Comparator: levofloxacin-based triple therapy
levofloxacin-based triple therapy for 10 days
lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)
Other Names:
  • Takepron
  • Cravit
  • Amoxicillin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication rate in the second line therapy
Time Frame: 6 weeks
Assessed by UBT
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse effect
Time Frame: 2 weeks
during treatment
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jyh-Ming Liou, MD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (Estimate)

February 22, 2012

Study Record Updates

Last Update Posted (Estimate)

February 2, 2015

Last Update Submitted That Met QC Criteria

January 30, 2015

Last Verified

January 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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