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

Functional Dyspepsia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667575
• Other study ID #: rjkls2012004
• Status: Completed
• Phase: Phase 4
• First received: August 15, 2012
• Last updated: June 1, 2013
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Functional Dyspepsia
• Helicobacter Pylori
• Peptic Ulcer

Intervention

Drug:
• Esomeprazole
antisecretary drug of the quadruple therapy
• Amoxicillin
antibiotic of the quadruple therapy
• Clarithromycin
antibiotic of the quadruple therapy
• Bismuth Potassium Citrate
one of a component of a quadruple therapy

Other:
• long duration (14 day)

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes