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Concomitant Therapy of H. Pylori

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Jin Il Kim, The Catholic University of Korea.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01922765
First Posted: August 14, 2013
Last Update Posted: February 11, 2014
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.
Collaborators:
Bucheon St. Mary's Hospital
St. Vincent's Medical Center
Information provided by (Responsible Party):
Jin Il Kim, The Catholic University of Korea
  Purpose
If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin, rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days(sequential), amoxicillin, clarithromycin, metronidazole, rabeprazole(concomitant), then the eradication rate of concomitant group will be the highest.

Condition Intervention Phase
Gastritis, Gastric Ulcer, and Duodenal Ulcer Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Concomitant Therapy for Eradication of Helicobacter Pylori

Resource links provided by NLM:


Further study details as provided by Jin Il Kim, The Catholic University of Korea:

Primary Outcome Measures:
  • Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori [ Time Frame: 6 months (Feb 2014) ]
    measure eradication rate of H.pylori with urea breath test(UBT) after 6 to 8 weeks of treatment


Estimated Enrollment: 540
Study Start Date: August 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AOC group
AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days
Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole
Other Names:
  • AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days
  • AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days
  • Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days
  • concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
Experimental: AOM group
AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days
Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole
Other Names:
  • AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days
  • AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days
  • Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days
  • concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
Experimental: Sequential group
Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days
Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole
Other Names:
  • AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days
  • AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days
  • Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days
  • concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
Experimental: concomitant group
concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole
Other Names:
  • AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days
  • AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days
  • Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days
  • concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days

Detailed Description:
  • Subject: The patient of gastritis, gastric ulcer, and duodenal ulcer infected with Helicobacter pylori
  • 170 subjects per group
  • Eradication regimens are as follows: AOC group, treated with amoxicillin, rabeprazole, clarithromycin for 7 days; AOM group, treated with amoxicillin, rabeprazole, metronidazole for 7 days; sequential group, treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days; concomitant group, treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients infected with Helicobacter pylori

Exclusion Criteria:

  • cancer
  • pregnancy
  • formerly treated with eradication
  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): NCT01922765


Locations
Korea, Republic of
Yeouido St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 150-713
Contact: Jin Il Kim, MD,PhD    82-10-6345-9977    jikim@catholic.ac.kr   
Principal Investigator: Jin Il Kim, MD,PhD         
Sponsors and Collaborators
The Catholic University of Korea
Bucheon St. Mary's Hospital
St. Vincent's Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin Il Kim, MD, PhD, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01922765     History of Changes
Other Study ID Numbers: concomitant
First Submitted: August 12, 2013
First Posted: August 14, 2013
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Jin Il Kim, The Catholic University of Korea:
Helicobacter
Eradication

Additional relevant MeSH terms:
Gastritis
Stomach Ulcer
Duodenal Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Amoxicillin
Clarithromycin
Metronidazole
Rabeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors