Trial Outcomes & Findings for Comparison of Two Rescue Therapies for Helicobacter Pylori Infection (NCT NCT02547012)
NCT ID: NCT02547012
Last Updated: 2019-03-14
Results Overview
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
six weeks after the end of anti-H pylori therapy.
Results posted on
2019-03-14
Participant Flow
recruitment period: Oct 2013 - Jul 2017 Type of location: Kaohsiung Veterans General Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital
None were excluded following participant enrollment.
Participant milestones
| Measure |
Esomeprazole+Amox+Levo+Tetra
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
esomeprazole+amox+levo+tetra: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
|
Esomeprazole+Amox+Levo
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
|
Overall Study
COMPLETED
|
24
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Rescue Therapies for Helicobacter Pylori Infection
Baseline characteristics by cohort
| Measure |
Esomeprazole+Amox+Levo+Tetra
n=24 Participants
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
esomeprazole+amox+levo+tetra: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
|
Esomeprazole+Amox+Levo
n=27 Participants
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.88 years
STANDARD_DEVIATION 9.13 • n=5 Participants
|
56.44 years
STANDARD_DEVIATION 15.02 • n=7 Participants
|
56.79 years
STANDARD_DEVIATION 12.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
24 participants
n=5 Participants
|
27 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
history of smoking
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: six weeks after the end of anti-H pylori therapy.Population: Intention to treat
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Outcome measures
| Measure |
Esomeprazole+Amox+Levo+Tetra
n=24 Participants
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
esomeprazole+amox+levo+tetra: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
|
Esomeprazole+Amox+Levo
n=27 Participants
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,
|
|---|---|---|
|
Number of Participants in Which H. Pylori Was Eradicated
|
13 participants
|
21 participants
|
Adverse Events
Esomeprazole+Amox+Levo+Tetra
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Esomeprazole+Amox+Levo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Esomeprazole+Amox+Levo+Tetra
n=24 participants at risk
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
esomeprazole+amox+levo+tetra: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
|
Esomeprazole+Amox+Levo
n=27 participants at risk
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
12/24 • Number of events 12 • 2 months
|
7.4%
2/27 • Number of events 2 • 2 months
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 2 • 2 months
|
11.1%
3/27 • Number of events 3 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place