Study of Levofloxacin-based Concomitant Therapy for H. Pylori Eradication in Diabetic Patients

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

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-09-30

Brief Summary

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The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel 10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential therapy.

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Detailed Description

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Conditions

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Helicobacter Pylori Infection

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-based concomitant

Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day10 Metronidazole 500 mg BID day1\~day10 Levofloxacin 500 mg QD day1\~day10

Group Type EXPERIMENTAL

Pantoprazole

Intervention Type DRUG

H. pylori eradication therapy

Amoxicillin

Intervention Type DRUG

H. pylori eradication therapy

Metronidazole

Intervention Type DRUG

H. pylori eradication therapy

Levofloxacin

Intervention Type DRUG

H. pylori eradication therapy

Sequential

Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day5 Metronidazole 500 mg BID day6\~day10 Clarithromycin 500 mg BID day6\~day10

Group Type ACTIVE_COMPARATOR

Pantoprazole

Intervention Type DRUG

H. pylori eradication therapy

Amoxicillin

Intervention Type DRUG

H. pylori eradication therapy

Metronidazole

Intervention Type DRUG

H. pylori eradication therapy

Clarithromycin

Intervention Type DRUG

H. pylori eradication therapy

Interventions

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Pantoprazole

H. pylori eradication therapy

Intervention Type DRUG

Amoxicillin

H. pylori eradication therapy

Intervention Type DRUG

Metronidazole

H. pylori eradication therapy

Intervention Type DRUG

Levofloxacin

H. pylori eradication therapy

Intervention Type DRUG

Clarithromycin

H. pylori eradication therapy

Intervention Type DRUG

Other Intervention Names

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Pantoloc Flagyl Cravit Klaricid

Eligibility Criteria

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Inclusion Criteria

* Diabetic patients with Helicobacter pylori infection

Exclusion Criteria

* Pregnancy or physically poor performance status
* Patients with contraindication for upper endoscopy
* Severe coagulopathy for endoscopic biopsy
* Chronic kidney disease (eGFR \< 50) or end stage renal disease
* Known allergy to interventional drugs
* Previous eradication failure

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No