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

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ClinicalTrials.gov Identifier: NCT01938534
Recruitment Status : Unknown
Verified December 2013 by Sun Gyo Lim, Ajou University School of Medicine.
Recruitment status was:  Recruiting
First Posted : September 10, 2013
Last Update Posted : January 1, 2014
Sponsor:
Information provided by (Responsible Party):
Sun Gyo Lim, Ajou University School of Medicine

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

Condition or disease Intervention/treatment Phase
Helicobacter Eradication Drug: Helicobacter pylori eradication Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2013
Estimated Primary Completion Date : December 2014

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



Primary Outcome Measures :
  1. Eradication rate of Helicobacter pylori [ Time Frame: one month ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938534


Contacts
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Contact: Ki Myung Lee, M.D., Ph.D. 82-31-219-6939 lkm5104@ajou.ac.kr
Contact: Sun Gyo Lim, M.D. 82-31-219-6939 mdlsk75@hanmail.net

Locations
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Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 443-721
Contact: Kee Myung Lee, M.D., Ph.D.    82-31-219-6939    lkm5104@ajou.ac.kr   
Contact: Sun Gyo Lim, M.D.    82-31-219-6939    mdlsk75@hanmail.net   
Principal Investigator: Kee Myung Lee, M.D., Ph.D.         
Sponsors and Collaborators
Ajou University School of Medicine

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Responsible Party: Sun Gyo Lim, Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01938534     History of Changes
Other Study ID Numbers: AJOU-EIRB-152692
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: January 1, 2014
Last Verified: December 2013