Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 15, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJune 4, 2013
June 1, 2013
9 months
August 15, 2012
June 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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.
2 months
Study Arms (3)
10 day Quadruple Therapy
EXPERIMENTALEsomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
10 day Triple therapy
ACTIVE COMPARATOREsomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days
14 day quadruple therapy
ACTIVE COMPARATOREsomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
Interventions
antisecretary drug of the quadruple therapy
antibiotic of the quadruple therapy
antibiotic of the quadruple therapy
one of a component of a quadruple therapy
Eligibility Criteria
You may qualify if:
- patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcers
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renji Hospital
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Lu, M.D.
Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of GI Division
Study Record Dates
First Submitted
August 15, 2012
First Posted
August 17, 2012
Study Start
August 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
June 4, 2013
Record last verified: 2013-06