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Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection

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ClinicalTrials.gov Identifier: NCT01742429
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):

December 2, 2012
December 5, 2012
August 29, 2014
November 2012
April 2013   (Final data collection date for primary outcome measure)
eradication rate [ Time Frame: 2 months ]
urease breath test
Same as current
Complete list of historical versions of study NCT01742429 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection
Not Provided
To test the efficacy of 14 day levofloxacin and bismuth-containing second-line therapy for resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cure Rate of Helicobacter Pylori Infection
  • Drug: Proton pump inhibitor
  • Drug: Bismuth subsalicylate
  • Drug: Metronidazole
    antibiotic
  • Drug: Tetracycline
    antibiotic
  • Drug: Amoxicillin
    antibiotic
  • Drug: Levofloxacin
    antibiotic
  • Experimental: Levofloxacin-bismuth therapy
    14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
    Interventions:
    • Drug: Proton pump inhibitor
    • Drug: Bismuth subsalicylate
    • Drug: Amoxicillin
    • Drug: Levofloxacin
  • Active Comparator: classical quadruple therapy
    14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline
    Interventions:
    • Drug: Proton pump inhibitor
    • Drug: Bismuth subsalicylate
    • Drug: Metronidazole
    • Drug: Tetracycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
April 2013
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before.

Exclusion Criteria:

  • patients less than 18 years old,
  • previous gastric surgery,
  • pregnancy,
  • lactation,
  • major systemic diseases,
  • administration of antibiotics,
  • bismuth,
  • antisecretory drugs in the preceding 8 weeks, or
  • allergy to any one of the medication used in the quadruple regimens.
Sexes Eligible for Study: All
19 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01742429
rjkls2012008
Yes
Not Provided
Not Provided
Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Not Provided
Shanghai Jiao Tong University School of Medicine
June 2013

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