Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment
Information source: Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Functional Dyspepsia; Peptic Ulcer
Intervention: Bismuth (Drug); Lansoprazole (Drug); Levofloxacin (Drug); Amoxicillin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Shanghai Jiao Tong University School of Medicine Official(s) and/or principal investigator(s):
Hong Lu, Principal Investigator, Affiliation: Shanghai Jiao-Tong University School of Medicine Renji Hospital
Summary
To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and
without Bismuth for H. pylori treatment.
Clinical Details
Official title: Levofloxacin-containing Therapy for Helicobacter Pylori Treatment
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: eradication rate of Helicobacter pylori
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Shanghai Jiao-Tong University School of Medicine Renji Hospital, Shanghai, Shanghai 200127, China
Additional Information
Starting date: May 2012
Last updated: December 12, 2012
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