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
  Purpose

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


Condition Intervention Phase
Helicobacter Infected Patients
Drug: sequential versus triple
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Jeil Pharmacy Co.:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: August 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418300

Locations
Korea, Republic of
Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Jun-Won Chung, M.D.    80-32-460-3778      
Sponsors and Collaborators
Jeil Pharmacy Co.
  More Information

No publications provided

Responsible Party: Gil Medical Center, IRB
ClinicalTrials.gov Identifier: NCT01418300     History of Changes
Other Study ID Numbers: GMC2010-088
Study First Received: August 13, 2011
Last Updated: August 16, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014