Trial Outcomes & Findings for Sequential and Hybrid Therapies for H Pylori Infection (NCT NCT01085786)
NCT ID: NCT01085786
Last Updated: 2015-09-21
Results Overview
evaluate eradication outcome by endoscopy with urease test or urea breath test
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
240 participants
Primary outcome timeframe
Dec 2010
Results posted on
2015-09-21
Participant Flow
recruitment period: Aug 2008 - May 2010
no significant events for the overall study
Participant milestones
| Measure |
14-day Sequential Treatment
One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
|
14-day Hybrid Treatment
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
117
|
|
Overall Study
COMPLETED
|
123
|
117
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sequential and Hybrid Therapies for H Pylori Infection
Baseline characteristics by cohort
| Measure |
14-day Sequential Treatment
n=123 Participants
One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
|
14-day Hybrid Treatment
n=117 Participants
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
188 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 11.8 • n=93 Participants
|
54.3 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
54.7 years
STANDARD_DEVIATION 12.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
120 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
120 Participants
n=27 Participants
|
|
Region of Enrollment
Taiwan
|
123 participants
n=93 Participants
|
117 participants
n=4 Participants
|
240 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Dec 2010evaluate eradication outcome by endoscopy with urease test or urea breath test
Outcome measures
| Measure |
14-day Sequential Treatment
n=123 Participants
One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
|
14-day Hybrid Treatment
n=117 Participants
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
|
|---|---|---|
|
Number of Participants in Which H. Pylori Was Eradicated
|
94 participants
Interval 90.0 to 98.0
|
99 participants
Interval 95.0 to 100.0
|
SECONDARY outcome
Timeframe: Dec 2010by standardized questionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Dec 2010Good compliance is defined as taking equal or more than 90% of eradication medicines
Outcome measures
Outcome data not reported
Adverse Events
14-day Sequential Treatment
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
14-day Hybrid Treatment
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
14-day Sequential Treatment
n=123 participants at risk
One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
|
14-day Hybrid Treatment
n=117 participants at risk
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
|
|---|---|---|
|
Gastrointestinal disorders
Taste perversion
|
8.9%
11/123 • Number of events 11 • period of data collection: 12 months
|
6.8%
8/117 • Number of events 8 • period of data collection: 12 months
|
|
Gastrointestinal disorders
nausea
|
10.6%
13/123 • Number of events 13 • period of data collection: 12 months
|
2.6%
3/117 • Number of events 3 • period of data collection: 12 months
|
|
Gastrointestinal disorders
diarrhea
|
3.3%
4/123 • Number of events 4 • period of data collection: 12 months
|
6.8%
8/117 • Number of events 8 • period of data collection: 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place