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

Phase 4

Completed

• Conditions: Functional Dyspepsia; Peptic Ulcer; Helicobacter Pylori
• Interventions: Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Bismuth Potassium Citrate; Other: long duration (14 day)

• Registration Number: NCT01667575
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-17
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-01
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 day Quadruple Therapy	Bismuth Potassium Citrate	Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
14 day quadruple therapy	Bismuth Potassium Citrate	Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
14 day quadruple therapy	long duration (14 day)	Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
10 day Quadruple Therapy	Amoxicillin	Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
10 day Quadruple Therapy	Esomeprazole	Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
10 day Quadruple Therapy	Clarithromycin	Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
10 day Triple therapy	Amoxicillin	Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days
10 day Triple therapy	Esomeprazole	Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days
10 day Triple therapy	Clarithromycin	Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days
14 day quadruple therapy	Esomeprazole	Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
14 day quadruple therapy	Clarithromycin	Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
14 day quadruple therapy	Amoxicillin	Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China