Concomitant Therapy of H. Pylori

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by The Catholic University of Korea
Sponsor:
Collaborator:
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
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: 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
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 July 23, 2014