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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Jeil Pharmacy Co..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Jeil Pharmacy Co.
ClinicalTrials.gov Identifier:
NCT01418300
First received: August 13, 2011
Last updated: August 16, 2011
Last verified: August 2011

August 13, 2011
August 16, 2011
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
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Conventional Triple Therapy Versus Sequential Therapy for H. Pylori in Peptic Ulcer Disease: Prospective Randomized Trial
Not Provided

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

Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
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
No
Korea, Republic of
 
NCT01418300
GMC2010-088
Not Provided
Gil Medical Center, IRB
Jeil Pharmacy Co.
Not Provided
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