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

December 31, 2013 updated by: Sun Gyo Lim, Ajou University School of Medicine
Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Suwon, Korea, Republic of, 443-721
        • Recruiting
        • Ajou University Hospital
        • Principal Investigator:
          • Kee Myung Lee, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental

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

for 10 days
Drug: Helicobacter pylori eradication
Active Comparator: Control
Tetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days
Drug: Helicobacter pylori eradication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eradication rate of Helicobacter pylori
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 5, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

January 1, 2014

Last Update Submitted That Met QC Criteria

December 31, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • AJOU-EIRB-152692

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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