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

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01667575

Collaborator

(none)

180

Enrollment

Location

Arms

Duration (Months)

20.1

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

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 Names: proton pump inhibitor Drug: Amoxicillin antibiotic of the quadruple therapy Other Names: antibiotic Drug: Clarithromycin antibiotic of the quadruple therapy Other Names: antibiotic Drug: Bismuth Potassium Citrate one of a component of a quadruple therapy Other Names: 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 Names: proton pump inhibitor Drug: Amoxicillin antibiotic of the quadruple therapy Other Names: antibiotic Drug: Clarithromycin antibiotic of the quadruple therapy Other Names: 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 Names: proton pump inhibitor Drug: Amoxicillin antibiotic of the quadruple therapy Other Names: antibiotic Drug: Clarithromycin antibiotic of the quadruple therapy Other Names: antibiotic Drug: Bismuth Potassium Citrate one of a component of a quadruple therapy Other Names: Bismuth Other: long duration (14 day)

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 Names:

proton pump inhibitor

Drug: Amoxicillin

antibiotic of the quadruple therapy

Other Names:

antibiotic

Drug: Clarithromycin

antibiotic of the quadruple therapy

Other Names:

antibiotic

Drug: Bismuth Potassium Citrate

one of a component of a quadruple therapy

Other Names:

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 Names:

proton pump inhibitor

Drug: Amoxicillin

antibiotic of the quadruple therapy

Other Names:

antibiotic

Drug: Clarithromycin

antibiotic of the quadruple therapy

Other Names:

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 Names:

proton pump inhibitor

Drug: Amoxicillin

antibiotic of the quadruple therapy

Other Names:

antibiotic

Drug: Clarithromycin

antibiotic of the quadruple therapy

Other Names:

antibiotic

Drug: Bismuth Potassium Citrate

one of a component of a quadruple therapy

Other Names:

Bismuth

Other: long duration (14 day)

Outcome Measures

Primary Outcome Measures

Eradication rate of Helicobacter pylori [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.