Trial Outcomes & Findings for Clarithromycin Resistant Tailored Therapy (NCT NCT01453036)

NCT ID: NCT01453036

Last Updated: 2013-09-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 924 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2013-09-27

Participant Flow

five hospitals affiliated with the Catholic University who visited from August 2011 to June 2012

Mutation test group ; Patients which are no detection of H. pyloriare were excluded

Participant milestones

Measure	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
Overall Study STARTED	308	308	308
Overall Study COMPLETED	282	193	277
Overall Study NOT COMPLETED	26	115	31

Reasons for withdrawal

Measure	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
Overall Study Lost to Follow-up	26	115	31

Baseline Characteristics

Clarithromycin Resistant Tailored Therapy

Baseline characteristics by cohort

Measure	Convential AOC Group n=308 Participants amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks	Mutation Test Group n=218 Participants 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 n=308 Participants 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 n=834 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	308 Participants n=5 Participants	218 Participants n=7 Participants	308 Participants n=5 Participants	834 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	54.0 years STANDARD_DEVIATION 12.0 • n=5 Participants	54.7 years STANDARD_DEVIATION 12.2 • n=7 Participants	56.2 years STANDARD_DEVIATION 13.2 • n=5 Participants	54.9 years STANDARD_DEVIATION 12.4 • n=4 Participants
Sex: Female, Male Female	205 Participants n=5 Participants	49 Participants n=7 Participants	150 Participants n=5 Participants	404 Participants n=4 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	169 Participants n=7 Participants	158 Participants n=5 Participants	430 Participants n=4 Participants
Region of Enrollment Korea, Republic of	308 participants n=5 Participants	218 participants n=7 Participants	308 participants n=5 Participants	834 participants n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: 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%

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.

Outcome measures

Measure	Convential AOC Group n=308 Participants amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks	Mutation Test Group n=218 Participants 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 n=308 Participants 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
Helicobacter Pylori Eradication Rate	75.9 percentage of participants Interval 70.2 to 81.6	91.2 percentage of participants Interval 88.9 to 93.4	79.1 percentage of participants Interval 73.7 to 84.5

Adverse Events

Convential AOC Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Convential AOM Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mutation Test Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jin Il Kim

The Catholic University of Korea

Phone: +82-2-3779-2382

Email: jikim@catholic.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place