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

NCT ID: NCT01667575

Last Updated: 2013-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Functional Dyspepsia Peptic Ulcer Helicobacter Pylori

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10 day Quadruple Therapy

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

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

antisecretary drug of the quadruple therapy

Amoxicillin

Intervention Type DRUG

antibiotic of the quadruple therapy

Clarithromycin

Intervention Type DRUG

antibiotic of the quadruple therapy

Bismuth Potassium Citrate

Intervention Type DRUG

one of a component of a quadruple therapy

10 day Triple therapy

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

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

antisecretary drug of the quadruple therapy

Amoxicillin

Intervention Type DRUG

antibiotic of the quadruple therapy

Clarithromycin

Intervention Type DRUG

antibiotic of the quadruple therapy

14 day quadruple therapy

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

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

antisecretary drug of the quadruple therapy

Amoxicillin

Intervention Type DRUG

antibiotic of the quadruple therapy

Clarithromycin

Intervention Type DRUG

antibiotic of the quadruple therapy

Bismuth Potassium Citrate

Intervention Type DRUG

one of a component of a quadruple therapy

long duration (14 day)

Intervention Type OTHER

Interventions

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Esomeprazole

antisecretary drug of the quadruple therapy

Intervention Type DRUG

Amoxicillin

antibiotic of the quadruple therapy

Intervention Type DRUG

Clarithromycin

antibiotic of the quadruple therapy

Intervention Type DRUG

Bismuth Potassium Citrate

one of a component of a quadruple therapy

Intervention Type DRUG

long duration (14 day)

Intervention Type OTHER

Other Intervention Names

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proton pump inhibitor antibiotic antibiotic Bismuth

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Dr. HONG LU

Professor of GI Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Lu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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rjkls2012004

Identifier Type: -

Identifier Source: org_study_id

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