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

This study is currently recruiting participants.
Verified December 2012 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: December 2, 2012
Last verified: December 2012

February 16, 2012
December 2, 2012
February 2012
December 2015   (final data collection date for primary outcome measure)
Eradication rate in the second line therapy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Assessed by UBT
Eradication rate in the second line therapy [ Time Frame: at least 6 weeks ] [ Designated as safety issue: No ]
Assessed by UBT
Complete list of historical versions of study NCT01537055 on ClinicalTrials.gov Archive Site
Incidence of adverse effect [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
during treatment
Same as current
Not Provided
Not Provided
 
Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy
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

About 440 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Eradication Rate for Helicobacter
  • 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
  • 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
  • Experimental: levofloxacin-based sequential therapy
    levofloxacin-based sequential therapy
    Intervention: Drug: levofloxacin-based sequential therapy
  • Active Comparator: levofloxacin-based triple therapy
    levofloxacin-based triple therapy for 10 days
    Intervention: Drug: levofloxacin-based triple therapy for 10 days
Liou JM, Chen CC, Chen MJ, Chang CY, Fang YJ, Lee JY, Sheng WH, Wang HP, Wu MS, Lin JT. Empirical modified sequential therapy containing levofloxacin and high-dose esomeprazole in second-line therapy for Helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2011 Aug;66(8):1847-52. doi: 10.1093/jac/dkr217. Epub 2011 May 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
440
April 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Jyh-Ming Liou, MD 886-972651883 dtmed046@pchome.com.tw
Taiwan
 
NCT01537055
201110021MD
Yes
National Taiwan University Hospital
National Taiwan University Hospital
E-DA Hospital
Principal Investigator: Jyh-Ming Liou, MD National Taiwan University Hospital
National Taiwan University Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP