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NCT Number: NCT01667575

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

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

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Key information

Conditions

Functional Dyspepsia Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Helicobacter Pylori Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole

Drug

antisecretary drug of the quadruple therapy

Other names: proton pump inhibitor

Amoxicillin

Drug

antibiotic of the quadruple therapy

Other names: antibiotic

Clarithromycin

Drug

antibiotic of the quadruple therapy

Other names: antibiotic

Bismuth Potassium Citrate

Drug

one of a component of a quadruple therapy

Other names: Bismuth

long duration (14 day)

Other

Primary outcomes

  1. Eradication rate of Helicobacter pylori

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 17, 2012
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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