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

This study is currently recruiting participants.

Verified August 2011 by Jeil Pharmacy Co.

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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 13, 2011
Last Updated Date	August 16, 2011
Start Date ^ICMJE	August 2010
Estimated Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 16, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01418300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of Conventional Triple Therapy Versus Sequential Therapy for H. Pylori in Peptic Ulcer Disease: Prospective Randomized Trial
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Helicobacter Infected Patients
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	150
Estimated Completion Date	December 2011
Estimated Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: peptic ulcer diseae two test positive rapid urease test, culture, histology Exclusion Criteria: lactating or pregnant previous stomach surgery severe underlying disease
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01418300
Other Study ID Numbers ^ICMJE	GMC2010-088
Has Data Monitoring Committee	Not Provided
Responsible Party	Gil Medical Center, IRB
Study Sponsor ^ICMJE	Jeil Pharmacy Co.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Jeil Pharmacy Co.
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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