Clarithromycin Resistant Tailored Therapy

This study has been completed.
Sponsor:
Collaborator:
Korean College of Helicobacter and Upper Gastrointestinal Research
Information provided by (Responsible Party):
Jin Il Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01453036
First received: September 29, 2011
Last updated: July 31, 2013
Last verified: July 2013
Results First Received: June 7, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Peptic Ulcer
Helicobacter Pylori Infection
Interventions: Procedure: 23S rRNA point mutation test of Helicobacter pylori
Procedure: UBT test & Gastroenterology with biopsy c silver stain

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
five hospitals affiliated with the Catholic University who visited from August 2011 to June 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Mutation test group ; Patients which are no detection of H. pyloriare were excluded

Reporting Groups
  Description
Conventional AOC Group The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
Mutation Test Group Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
Convential AOM Group The investigators do not perform mutation test in the conventional group apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week

Participant Flow:   Overall Study
    Conventional AOC Group     Mutation Test Group     Convential AOM Group  
STARTED     308     308     308  
COMPLETED     282     193     277  
NOT COMPLETED     26     115     31  
Lost to Follow-up                 26                 115                 31  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Convential AOC Group amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
Mutation Test Group Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
Convential AOM Group The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks
Total Total of all reporting groups

Baseline Measures
    Convential AOC Group     Mutation Test Group     Convential AOM Group     Total  
Number of Participants  
[units: participants]
  308     218     308     834  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     308     218     308     834  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  54.0  ± 12.0     54.7  ± 12.2     56.2  ± 13.2     54.9  ± 12.4  
Gender  
[units: participants]
       
Female     205     49     150     404  
Male     103     169     158     430  
Region of Enrollment  
[units: participants]
       
Korea, Republic of     308     218     308     834  



  Outcome Measures

1.  Primary:   Helicobacter Pylori Eradication Rate   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Jin Il Kim
Organization: The Catholic University of Korea
phone: +82-2-3779-2382
e-mail: jikim@catholic.ac.kr


Publications of Results:

Responsible Party: Jin Il Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01453036     History of Changes
Other Study ID Numbers: CUK
Study First Received: September 29, 2011
Results First Received: June 7, 2012
Last Updated: July 31, 2013
Health Authority: Korea: Institutional Review Board