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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
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring eradication, helicobacter pylori, bismuth

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 5, 2012
Last Updated
December 12, 2012
Sponsor
Shanghai Jiao Tong University School of Medicine
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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

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