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Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori

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ClinicalTrials.gov Identifier: NCT01667575
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. HONG LU, Shanghai Jiao Tong University School of Medicine

Brief Summary:
The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Peptic Ulcer Helicobacter Pylori Drug: Esomeprazole Drug: Amoxicillin Drug: Clarithromycin Drug: Bismuth Potassium Citrate Other: long duration (14 day) Phase 4

Detailed Description:
The success rate of currently recommended triple therapy with a proton pump inhibitor (PPI) plus amoxicillin and clarithromycin has fallen into the unacceptable range. The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment, while ten day triple therapy is used as control.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 10 day Quadruple Therapy
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
Drug: Esomeprazole
antisecretary drug of the quadruple therapy
Other Name: proton pump inhibitor
Drug: Amoxicillin
antibiotic of the quadruple therapy
Other Name: antibiotic
Drug: Clarithromycin
antibiotic of the quadruple therapy
Other Name: antibiotic
Drug: Bismuth Potassium Citrate
one of a component of a quadruple therapy
Other Name: Bismuth
Active Comparator: 10 day Triple therapy
Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days
Drug: Esomeprazole
antisecretary drug of the quadruple therapy
Other Name: proton pump inhibitor
Drug: Amoxicillin
antibiotic of the quadruple therapy
Other Name: antibiotic
Drug: Clarithromycin
antibiotic of the quadruple therapy
Other Name: antibiotic
Active Comparator: 14 day quadruple therapy
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
Drug: Esomeprazole
antisecretary drug of the quadruple therapy
Other Name: proton pump inhibitor
Drug: Amoxicillin
antibiotic of the quadruple therapy
Other Name: antibiotic
Drug: Clarithromycin
antibiotic of the quadruple therapy
Other Name: antibiotic
Drug: Bismuth Potassium Citrate
one of a component of a quadruple therapy
Other Name: Bismuth
Other: long duration (14 day)



Primary Outcome Measures :
  1. Eradication rate of Helicobacter pylori [ Time Frame: 2 months ]
    To calculate and compare the efficacy of 10 day and 14 day triple therapies with and without bismuth,to examine whether long duration and addition of bismuth affects the eradication.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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 ulcers

Exclusion Criteria:

  • patients less than 18 years old, with history of H. pylori infection treatment, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks, or allergy to any one of the given medication in the regimens.

Information from the National Library of Medicine

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): NCT01667575


Locations
China, Shanghai
Renji Hospital
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Hong Lu, M.D. Shanghai Jiao Tong University School of Medicine

Responsible Party: Dr. HONG LU, Professor of GI Division, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01667575     History of Changes
Other Study ID Numbers: rjkls2012004
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Dyspepsia
Peptic Ulcer
Signs and Symptoms, Digestive
Signs and Symptoms
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Bacterial Agents
Amoxicillin
Clarithromycin
Antibiotics, Antitubercular
Citric Acid
Esomeprazole
Proton Pump Inhibitors
Bismuth
Potassium Citrate
Anti-Infective Agents
Antitubercular Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors