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Comparison of Conventional Triple Therapy Versus Sequential Therapy for H. Pylori in Peptic Ulcer Disease: Prospective Randomized Trial

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ClinicalTrials.gov Identifier: NCT01418300
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
Jun-Won Chung, Jeil Pharmacy Co.

Brief Summary:
The purpose of this study is to improve first line Helicobacter pylori eradication rate and to compare the sequential versus conventional triple therapy.

Condition or disease Intervention/treatment Phase
Helicobacter Infected Patients Drug: sequential versus triple Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2010
Primary Completion Date : August 2011
Study Completion Date : December 2011

Arm Intervention/treatment
Active Comparator: sequential therapy
first five day amoxicillin+PPI later five day PPI+clarithromycin+metronidazole
Drug: sequential versus triple
sequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe lansoprazole 30mg bid+clarithromycin 500mg bid+amoxicillin 1000mg bid
Active Comparator: conventional triple thearpy
PPI+amoxicillin+clarithromycin
Drug: sequential versus triple
sequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe lansoprazole 30mg bid+clarithromycin 500mg bid+amoxicillin 1000mg bid



Primary Outcome Measures :
  1. the eradication rate by urea breath test [ Time Frame: 4-6 week later after completion of therapy ]
    to compare the eradication rate (intention-to-treat and per protocol) by urea breath test at least four weeks after treatment



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

Inclusion Criteria:

  • peptic ulcer diseae
  • two test positive rapid urease test, culture, histology

Exclusion Criteria:

  • lactating or pregnant
  • previous stomach surgery
  • severe underlying disease

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): NCT01418300


Locations
Korea, Republic of
Gil Medical Center
Incheon, Korea, Republic of
Sponsors and Collaborators
Jun-Won Chung

Responsible Party: Jun-Won Chung, principal investigator, Jeil Pharmacy Co.
ClinicalTrials.gov Identifier: NCT01418300     History of Changes
Other Study ID Numbers: GMC2010-088
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: August 2011

Additional relevant MeSH terms:
Amoxicillin
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors