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Clarithromycin Resistant Tailored Therapy

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ClinicalTrials.gov Identifier: NCT01453036
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
Sponsor:
Collaborator:
Korean College of Helicobacter and Upper Gastrointestinal Research
Information provided by (Responsible Party):
Jin Il Kim, The Catholic University of Korea

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 924

Recruitment Details five hospitals affiliated with the Catholic University who visited from August 2011 to June 2012
Pre-assignment Details Mutation test group ; Patients which are no detection of H. pyloriare were excluded
Arm/Group Title Conventional AOC Group Mutation Test Group Convential AOM Group
Hide Arm/Group Description 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 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 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
Period Title: Overall Study
Started 308 308 308
Completed 282 193 277
Not Completed 26 115 31
Reason Not Completed
Lost to Follow-up             26             115             31
Arm/Group Title Convential AOC Group Mutation Test Group Convential AOM Group Total
Hide Arm/Group Description amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks 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 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 of all reporting groups
Overall Number of Baseline Participants 308 218 308 834
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants 218 participants 308 participants 834 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
308
 100.0%
218
 100.0%
308
 100.0%
834
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 308 participants 218 participants 308 participants 834 participants
54.0  (12.0) 54.7  (12.2) 56.2  (13.2) 54.9  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants 218 participants 308 participants 834 participants
Female
205
  66.6%
49
  22.5%
150
  48.7%
404
  48.4%
Male
103
  33.4%
169
  77.5%
158
  51.3%
430
  51.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 308 participants 218 participants 308 participants 834 participants
308 218 308 834
1.Primary Outcome
Title Helicobacter Pylori Eradication Rate
Hide Description Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each convential AOC, AOM group : 308 patients Mutation test gorup : H. pylori was not detected by PCR 90 patient , total 218 patient predicted prevalence – 50%, expected dropout rate -15%, predicted eradication rate – 80%, significance level - 0.05, statistical power - 90%
Arm/Group Title Convential AOC Group Mutation Test Group Convential AOM Group
Hide Arm/Group Description:
amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
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
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
Overall Number of Participants Analyzed 308 218 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.9
(70.2 to 81.6)
91.2
(88.9 to 93.4)
79.1
(73.7 to 84.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Convential AOC Group Convential AOM Group Mutation Test Group
Hide Arm/Group Description amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks [Not Specified] [Not Specified]
All-Cause Mortality
Convential AOC Group Convential AOM Group Mutation Test Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Convential AOC Group Convential AOM Group Mutation Test Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/308 (0.00%)   0/308 (0.00%)   0/218 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Convential AOC Group Convential AOM Group Mutation Test Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/308 (0.00%)   0/308 (0.00%)   0/218 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jin Il Kim
Organization: The Catholic University of Korea
Phone: +82-2-3779-2382
Responsible Party: Jin Il Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01453036     History of Changes
Other Study ID Numbers: CUK
First Submitted: September 29, 2011
First Posted: October 17, 2011
Results First Submitted: June 7, 2012
Results First Posted: September 27, 2013
Last Update Posted: September 27, 2013