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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
History of Changes
  Purpose

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


Condition Intervention Phase
Functional Dyspepsia
Peptic Ulcer
 Drug: Bismuth
Drug: Lansoprazole
Drug: Levofloxacin
Drug: Amoxicillin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Levofloxacin-containing Therapy for Helicobacter Pylori Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • eradication rate of Helicobacter pylori [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 161
Study Start Date: May 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levofloxacin-triple therapy
Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin
 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
Experimental: Levofloxacin-quadruple therapy
Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin
 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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667718

Locations
China, Shanghai
Shanghai Jiao-Tong University School of Medicine Renji Hospital
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Hong Lu Shanghai Jiao-Tong University School of Medicine Renji Hospital
  More Information

No publications provided

Responsible Party: Dr. HONG LU, Professor of GI Division, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01667718     History of Changes
Other Study ID Numbers: rjkls2012011
Study First Received: June 5, 2012
Last Updated: December 12, 2012
Health Authority: Renji Hospital, Shanghai Jiaotong University, School of Medicine:China

Keywords provided by Shanghai Jiao Tong University School of Medicine:
eradication
helicobacter pylori
bismuth

Additional relevant MeSH terms:
Dyspepsia
Peptic Ulcer
Ulcer
Signs and Symptoms, Digestive
Signs and Symptoms
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Amoxicillin
Ofloxacin
Lansoprazole
Bismuth
 Potassium Citrate
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Diuretics

ClinicalTrials.gov processed this record on May 21, 2013