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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Taiwan University Hospital
Sponsor:
Collaborator:
E-DA Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01537055
First received: February 16, 2012
Last updated: August 2, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Eradication Rate for Helicobacter
Drug: levofloxacin-based sequential therapy
Drug: levofloxacin-based triple therapy for 10 days
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Eradication rate in the second line therapy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Assessed by UBT


Secondary Outcome Measures:
  • Incidence of adverse effect [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    during treatment


Estimated Enrollment: 600
Study Start Date: February 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: levofloxacin-based sequential therapy
levofloxacin-based sequential therapy
Drug: 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
Drug: 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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537055

Contacts
Contact: Jyh-Ming Liou, MD 886-972651883 dtmed046@pchome.com.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Jyh-Ming Liou, MD    886-972651883    dtmed046@pchome.com.tw   
Sponsors and Collaborators
National Taiwan University Hospital
E-DA Hospital
Investigators
Principal Investigator: Jyh-Ming Liou, MD National Taiwan University Hospital
  More Information

Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01537055     History of Changes
Other Study ID Numbers: 201110021MD
Study First Received: February 16, 2012
Last Updated: August 2, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Taiwan University Hospital:
H pylori eradication

Additional relevant MeSH terms:
Amoxicillin
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014