Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment
Primary Purpose
Functional Dyspepsia, Peptic Ulcer
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bismuth
Lansoprazole
Levofloxacin
Amoxicillin
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia focused on measuring eradication, helicobacter pylori, bismuth
Eligibility 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
Sites / Locations
- Shanghai Jiao-Tong University School of Medicine Renji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Levofloxacin-triple therapy
Levofloxacin-quadruple therapy
Arm Description
Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin
Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin
Outcomes
Primary Outcome Measures
eradication rate of Helicobacter pylori
Secondary Outcome Measures
Full Information
NCT ID
NCT01667718
First Posted
June 5, 2012
Last Updated
December 12, 2012
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01667718
Brief Title
Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment
Official Title
Levofloxacin-containing Therapy for Helicobacter Pylori Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Peptic Ulcer
Keywords
eradication, helicobacter pylori, bismuth
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levofloxacin-triple therapy
Arm Type
Active Comparator
Arm Description
Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin
Arm Title
Levofloxacin-quadruple therapy
Arm Type
Experimental
Arm Description
Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin
Intervention Type
Drug
Intervention Name(s)
Bismuth
Other Intervention Name(s)
Bismuth potassium citrate
Intervention Description
Bismuth 220mg b.i.d for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
Proton Pump Inhibitor
Intervention Description
Lansoprazole 30 mg b.i.d.for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
Levofloxacin 0.5 q.d. for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
Amoxicillin 1 g b.i.d. for 2 weeks
Primary Outcome Measure Information:
Title
eradication rate of Helicobacter pylori
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Lu
Organizational Affiliation
Shanghai Jiao-Tong University School of Medicine Renji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Jiao-Tong University School of Medicine Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Learn more about this trial
Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment
We'll reach out to this number within 24 hrs