Concomitant Therapy of H. Pylori
Evaluation of the Efficacy of Concomitant Therapy for Eradication of Helicobacter Pylori
1 other identifier
interventional
540
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 12, 2013
CompletedFirst Posted
Study publicly available on registry
August 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 11, 2014
February 1, 2014
6 months
August 12, 2013
February 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori
measure eradication rate of H.pylori with urea breath test(UBT) after 6 to 8 weeks of treatment
6 months (Feb 2014)
Study Arms (4)
AOC group
EXPERIMENTALAOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days
AOM group
EXPERIMENTALAOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days
Sequential group
EXPERIMENTALSequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days
concomitant group
EXPERIMENTALconcomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- patients infected with Helicobacter pylori
You may not qualify if:
- cancer
- pregnancy
- formerly treated with eradication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Catholic University of Korealead
- Bucheon St. Mary's Hospitalcollaborator
- St Vincent's Hospitalcollaborator
Study Sites (1)
Yeouido St. Mary's Hospital
Seoul, 150-713, South Korea
Related Publications (1)
Lee HJ, Kim JI, Lee JS, Jun EJ, Oh JH, Cheung DY, Chung WC, Kim BW, Kim SS. Concomitant therapy achieved the best eradication rate for Helicobacter pylori among various treatment strategies. World J Gastroenterol. 2015 Jan 7;21(1):351-9. doi: 10.3748/wjg.v21.i1.351.
PMID: 25574111DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 12, 2013
First Posted
August 14, 2013
Study Start
August 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
February 11, 2014
Record last verified: 2014-02