Back to resultsEfficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori
Primary Purpose
Functional Dyspepsia, Peptic Ulcer, Helicobacter Pylori
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Esomeprazole
Amoxicillin
Clarithromycin
Bismuth Potassium Citrate
long duration (14 day)
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia
Eligibility 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.
Sites / Locations
- Renji Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
10 day Quadruple Therapy
10 day Triple therapy
14 day quadruple therapy
Arm Description
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
Outcomes
Primary Outcome Measures
Eradication rate of Helicobacter pylori
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01667575
First Posted
August 15, 2012
Last Updated
June 1, 2013
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01667575
Brief Title
Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Peptic Ulcer, Helicobacter Pylori
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 day Quadruple Therapy
Arm Type
Experimental
Arm Description
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
Arm Title
10 day Triple therapy
Arm Type
Active Comparator
Arm Description
Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days
Arm Title
14 day quadruple therapy
Arm Type
Active Comparator
Arm Description
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
proton pump inhibitor
Intervention Description
antisecretary drug of the quadruple therapy
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
antibiotic
Intervention Description
antibiotic of the quadruple therapy
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Other Intervention Name(s)
antibiotic
Intervention Description
antibiotic of the quadruple therapy
Intervention Type
Drug
Intervention Name(s)
Bismuth Potassium Citrate
Other Intervention Name(s)
Bismuth
Intervention Description
one of a component of a quadruple therapy
Intervention Type
Other
Intervention Name(s)
long duration (14 day)
Primary Outcome Measure Information:
Title
Eradication rate of Helicobacter pylori
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Lu, M.D.
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori
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