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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01667718
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : December 13, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. HONG LU, Shanghai Jiao Tong University School of Medicine

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

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Peptic Ulcer Drug: Bismuth Drug: Lansoprazole Drug: Levofloxacin Drug: Amoxicillin Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Levofloxacin-containing Therapy for Helicobacter Pylori Treatment
Study Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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Arms and Interventions
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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 Name: 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: 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

Drug: Amoxicillin
Amoxicillin 1 g b.i.d. for 2 weeks


Outcome Measures
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Primary Outcome Measures :
  1. eradication rate of Helicobacter pylori [ Time Frame: 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667718


Locations
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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
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Principal Investigator: Hong Lu Shanghai Jiao-Tong University School of Medicine Renji Hospital
More Information
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Responsible Party: Dr. HONG LU, Professor of GI Division, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01667718    
Other Study ID Numbers: rjkls2012011
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012
Keywords provided by Dr. HONG LU, Shanghai Jiao Tong University School of Medicine:
eradication
helicobacter pylori
bismuth
Additional relevant MeSH terms:
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Peptic Ulcer
Dyspepsia
Signs and Symptoms, Digestive
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Levofloxacin
Potassium Citrate
Lansoprazole
Dexlansoprazole
Bismuth
Proton Pump Inhibitors
 Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Antacids
Diuretics
Natriuretic Agents