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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. HONG LU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01667575
First received: August 15, 2012
Last updated: June 1, 2013
Last verified: June 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]
    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.


Enrollment: 180
Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 15, 2012
Last Updated: June 1, 2013
Health Authority: China: Food and Drug Administration

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
Anti-Bacterial Agents
Clarithromycin
Antibiotics, Antitubercular
Bismuth
Potassium Citrate
Proton Pump Inhibitors
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Enzyme Inhibitors
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants

ClinicalTrials.gov processed this record on April 23, 2014