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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Peptic Ulcer; Functional Dyspepsia; Helicobacter Pylori

Treatments: Other: long duration (14 day); Drug: Clarithromycin; Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT01667575

rjkls2012004

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

10 day Quadruple Therapy

Experimental group

Description:

Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days

Treatment:

Drug: Bismuth Potassium Citrate

Drug: Amoxicillin

Drug: Esomeprazole

Drug: Clarithromycin

10 day Triple therapy

Active Comparator group

Description:

Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days

Treatment:

Drug: Amoxicillin

Drug: Esomeprazole

Drug: Clarithromycin

14 day quadruple therapy

Active Comparator group

Description:

Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days

Treatment:

Drug: Bismuth Potassium Citrate

Drug: Amoxicillin

Drug: Esomeprazole

Drug: Clarithromycin

Other: long duration (14 day)