Concomitant Therapy of H. Pylori

This study is currently recruiting participants.
Verified February 2014 by The Catholic University of Korea
Sponsor:
Collaborators:
Euijeongbu St.Mary's Hospital
Bucheon St.Mary's Hospital
St.Vincent Hospital
Information provided by (Responsible Party):
Jin Il Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01922765
First received: August 12, 2013
Last updated: February 9, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients infected with Helicobacter pylori

Exclusion Criteria:

  • cancer
  • pregnancy
  • formerly treated with eradication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Euijeongbu St.Mary's Hospital
Bucheon St.Mary's Hospital
St.Vincent Hospital
  More Information

No publications provided

Responsible Party: Jin Il Kim, MD, PhD, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01922765     History of Changes
Other Study ID Numbers: concomitant
Study First Received: August 12, 2013
Last Updated: February 9, 2014
Health Authority: Korea: Ministry of Education, Science, and Technology

Keywords provided by The Catholic University of Korea:
Helicobacter
Eradication

Additional relevant MeSH terms:
Stomach Ulcer
Duodenal Ulcer
Gastritis
Ulcer
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Stomach Diseases
Pathologic Processes
Amoxicillin
Clarithromycin
Metronidazole
Rabeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 22, 2014