Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use

NCT ID: NCT01938534

Last Updated: 2014-01-01

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Brief Summary

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Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.

Detailed Description

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Antibiotics resistant is serious problem in helicobacter pylori eradication. Clarithromycin is very important antibiotics in eradication. But clarithromycin resistance is increased. Major cause of clarithromycin resistance is past consumption of macrolide. Thus the investigators propose eradication of macrolide used group bismuth contained four drugs therapy.

Conditions

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Helicobacter Eradication

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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Experimental

Omeprazole 30mg twice Clarithromycin 500mg twice Amoxicillin 1000mg twice

for 10 days

Group Type EXPERIMENTAL

Helicobacter pylori eradication

Intervention Type DRUG

Control

Tetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days

Group Type ACTIVE_COMPARATOR

Helicobacter pylori eradication

Intervention Type DRUG

Interventions

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Helicobacter pylori eradication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Peptic ulcer disease
* Gastric MALT lymphoma
* Early gastric cancer
* Familial history of gastric cancer
* Idiopathic iron deficiency
* Chronic idiopathic thrombocytopenia
* Atrophic gastritis
* Helicobacter infected dyspepsia
* Long term NSAIDs use

Exclusion Criteria

* Pregnant
* Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks
* Previous stomach surgery
* Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder)
* Previous Helicobacter eradication
* Allergy for Helicobacter eradication medicine
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sun Gyo Lim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ajou University Hospital

Suwon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ki Myung Lee, M.D., Ph.D.

Role: CONTACT

82-31-219-6939

Sun Gyo Lim, M.D.

Role: CONTACT

82-31-219-6939

Facility Contacts

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Kee Myung Lee, M.D., Ph.D.

Role: primary

82-31-219-6939

Sun Gyo Lim, M.D.

Role: backup

82-31-219-6939

Other Identifiers

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AJOU-EIRB-152692

Identifier Type: -

Identifier Source: org_study_id

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