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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jun-Won Chung, Jeil Pharmacy Co.
ClinicalTrials.gov Identifier:
NCT01418300
First received: August 13, 2011
Last updated: April 26, 2015
Last verified: August 2011

August 13, 2011
April 26, 2015
August 2010
August 2011   (final data collection date for primary outcome measure)
the eradication rate by urea breath test [ Time Frame: 4-6 week later after completion of therapy ] [ Designated as safety issue: No ]
to compare the eradication rate (intention-to-treat and per protocol) by urea breath test at least four weeks after treatment
Same as current
Complete list of historical versions of study NCT01418300 on ClinicalTrials.gov Archive Site
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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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The purpose of this study is to improve first line Helicobacter pylori eradication rate and to compare the sequential versus conventional triple therapy.
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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Helicobacter Infected Patients
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: sequential therapy
    first five day amoxicillin+PPI later five day PPI+clarithromycin+metronidazole
    Intervention: Drug: sequential versus triple
  • Active Comparator: conventional triple thearpy
    PPI+amoxicillin+clarithromycin
    Intervention: Drug: sequential versus triple
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
December 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • lactating or pregnant
  • previous stomach surgery
  • severe underlying disease
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01418300
GMC2010-088
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Jun-Won Chung, Jeil Pharmacy Co.
Jun-Won Chung
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Not Provided
Jeil Pharmacy Co.
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP