We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418300
First Posted: August 17, 2011
Last Update Posted: April 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jun-Won Chung, Jeil Pharmacy Co.
  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: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Jun-Won Chung, Jeil Pharmacy Co.:

Primary Outcome Measures:
  • 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


Enrollment: 159
Study Start Date: August 2010
Study Completion Date: December 2011
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Jun-Won Chung, principal investigator, Jeil Pharmacy Co.
ClinicalTrials.gov Identifier: NCT01418300     History of Changes
Other Study ID Numbers: GMC2010-088
First Submitted: August 13, 2011
First Posted: August 17, 2011
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