Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. HONG LU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01667718
First received: June 5, 2012
Last updated: December 12, 2012
Last verified: December 2012

June 5, 2012
December 12, 2012
May 2012
October 2012   (final data collection date for primary outcome measure)
eradication rate of Helicobacter pylori [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01667718 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment
Levofloxacin-containing Therapy for Helicobacter Pylori Treatment

To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.

The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Functional Dyspepsia
  • Peptic Ulcer
  • Drug: Bismuth
    Bismuth 220mg b.i.d for 2 weeks
    Other Name: Bismuth potassium citrate
  • Drug: Lansoprazole
    Lansoprazole 30 mg b.i.d.for 2 weeks
    Other Name: Proton Pump Inhibitor
  • Drug: Levofloxacin
    Levofloxacin 0.5 q.d. for 2 weeks
    Other Name: Levofloxacin
  • Drug: Amoxicillin
    Amoxicillin 1 g b.i.d. for 2 weeks
    Other Name: Amoxicillin
  • Active Comparator: Levofloxacin-triple therapy
    Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin
    Interventions:
    • Drug: Lansoprazole
    • Drug: Levofloxacin
    • Drug: Amoxicillin
  • Experimental: Levofloxacin-quadruple therapy
    Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin
    Interventions:
    • Drug: Bismuth
    • Drug: Lansoprazole
    • Drug: Levofloxacin
    • Drug: Amoxicillin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
161
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer

Exclusion Criteria:

  • patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01667718
rjkls2012011
No
Dr. HONG LU, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Principal Investigator: Hong Lu Shanghai Jiao-Tong University School of Medicine Renji Hospital
Shanghai Jiao Tong University School of Medicine
December 2012

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