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Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment

NCT ID: NCT01667718

Last Updated: 2012-12-13

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

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-10-31

Brief Summary

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To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.

Detailed Description

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The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Conditions

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Functional Dyspepsia Peptic Ulcer

Keywords

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eradication helicobacter pylori bismuth

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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Levofloxacin-triple therapy

Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

Lansoprazole 30 mg b.i.d.for 2 weeks

Levofloxacin

Intervention Type DRUG

Levofloxacin 0.5 q.d. for 2 weeks

Amoxicillin

Intervention Type DRUG

Amoxicillin 1 g b.i.d. for 2 weeks

Levofloxacin-quadruple therapy

Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin

Group Type EXPERIMENTAL

Bismuth

Intervention Type DRUG

Bismuth 220mg b.i.d for 2 weeks

Lansoprazole

Intervention Type DRUG

Lansoprazole 30 mg b.i.d.for 2 weeks

Levofloxacin

Intervention Type DRUG

Levofloxacin 0.5 q.d. for 2 weeks

Amoxicillin

Intervention Type DRUG

Amoxicillin 1 g b.i.d. for 2 weeks

Interventions

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Bismuth

Bismuth 220mg b.i.d for 2 weeks

Intervention Type DRUG

Lansoprazole

Lansoprazole 30 mg b.i.d.for 2 weeks

Intervention Type DRUG

Levofloxacin

Levofloxacin 0.5 q.d. for 2 weeks

Intervention Type DRUG

Amoxicillin

Amoxicillin 1 g b.i.d. for 2 weeks

Intervention Type DRUG

Other Intervention Names

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Bismuth potassium citrate Proton Pump Inhibitor

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 ulcer

Exclusion Criteria

* patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications
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

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao-Tong University School of Medicine Renji Hospital

Locations

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Shanghai Jiao-Tong University School of Medicine Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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rjkls2012011

Identifier Type: -

Identifier Source: org_study_id