Empirical Rescue Therapies of Helicobacter Pylori Infection

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

424 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-10-31

Brief Summary

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The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. It is necessary to assess the efficacy and safety of these four bismuth-containing quadruple regimens with above antibiotics as empirical rescue therapies for H. pylori eradication.

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Detailed Description

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Conditions

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Functional Dyspepsia Scarred Peptic Ulcer

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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tetracycline/furazolidone

one of the four empirical rescue therapies

Group Type EXPERIMENTAL

Proton Pump Inhibitor

Intervention Type DRUG

Bismuth

Intervention Type DRUG

Tetracycline

Intervention Type DRUG

Furazolidone

Intervention Type DRUG

amoxicillin/tetracycline

one of the four empirical rescue therapies

Group Type EXPERIMENTAL

Proton Pump Inhibitor

Intervention Type DRUG

Bismuth

Intervention Type DRUG

Tetracycline

Intervention Type DRUG

Amoxicillin

Intervention Type DRUG

amoxicillin/furazolidone

one of the four empirical rescue therapies

Group Type EXPERIMENTAL

Proton Pump Inhibitor

Intervention Type DRUG

Bismuth

Intervention Type DRUG

Furazolidone

Intervention Type DRUG

Amoxicillin

Intervention Type DRUG

tetracycline /metronidazole

Classical rescue therapy

Group Type ACTIVE_COMPARATOR

Proton Pump Inhibitor

Intervention Type DRUG

Bismuth

Intervention Type DRUG

Metronidazole

Intervention Type DRUG

Tetracycline

Intervention Type DRUG

Interventions

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Proton Pump Inhibitor

Intervention Type DRUG

Bismuth

Intervention Type DRUG

Metronidazole

Intervention Type DRUG

Tetracycline

Intervention Type DRUG

Furazolidone

Intervention Type DRUG

Amoxicillin

Intervention Type DRUG

Other Intervention Names

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Lansoprazole Bismuth potassium citrate

Eligibility Criteria

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Inclusion Criteria

* H. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who had previously failed one or more eradication regimens containing clarithromycin, metronidazole and/or amoxicillin.

Exclusion Criteria

* less than 18 years old, never receiving eradication treatment before, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No