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

December 12, 2012 updated by: Dr. HONG LU, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Shanghai Jiao-Tong University School of Medicine Renji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Levofloxacin-triple therapy
Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin
Drug: Lansoprazole
Lansoprazole 30 mg b.i.d.for 2 weeks
Other Names:
  • Proton Pump Inhibitor
Drug: Levofloxacin
Levofloxacin 0.5 q.d. for 2 weeks
Drug: Amoxicillin
Amoxicillin 1 g b.i.d. for 2 weeks
Experimental: Levofloxacin-quadruple therapy
Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin
Drug: Lansoprazole
Lansoprazole 30 mg b.i.d.for 2 weeks
Other Names:
  • Proton Pump Inhibitor
Drug: Levofloxacin
Levofloxacin 0.5 q.d. for 2 weeks
Drug: Amoxicillin
Amoxicillin 1 g b.i.d. for 2 weeks
Drug: Bismuth
Bismuth 220mg b.i.d for 2 weeks
Other Names:
  • Bismuth potassium citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
eradication rate of Helicobacter pylori
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Hong Lu, Shanghai Jiao-Tong University School of Medicine Renji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Estimate)

December 13, 2012

Last Update Submitted That Met QC Criteria

December 12, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjkls2012011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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