Trial Outcomes & Findings for Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy (NCT NCT02547038)
NCT ID: NCT02547038
Last Updated: 2019-06-10
Results Overview
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
352 participants
Primary outcome timeframe
sixth week after the end of anti- H. pylori therapy
Results posted on
2019-06-10
Participant Flow
recruitment period: August 2015 through February 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 |
Pantoprazole+Bismuth+Tetra+Metro
pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
|
(Panto+Amox+Clar+Metr)+(Panto+Amox)
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
176
|
|
Overall Study
COMPLETED
|
173
|
174
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Pantoprazole+Bismuth+Tetra+Metro
pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
|
(Panto+Amox+Clar+Metr)+(Panto+Amox)
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy
Baseline characteristics by cohort
| Measure |
Pantoprazole+Bismuth+Tetra+Metro
n=176 Participants
pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
|
(Panto+Amox+Clar+Metr)+(Panto+Amox)
n=176 Participants
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
|
Total
n=352 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
145 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
282 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
54.5 years
STANDARD_DEVIATION 12.9 • n=107 Participants
|
54.2 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
184 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
168 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
176 Participants
n=99 Participants
|
176 Participants
n=107 Participants
|
352 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
176 participants
n=99 Participants
|
176 participants
n=107 Participants
|
352 participants
n=206 Participants
|
|
History of smoking
|
24 participants
n=99 Participants
|
35 participants
n=107 Participants
|
59 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: sixth week after the end of anti- H. pylori therapyPopulation: Intention to treat
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori)
Outcome measures
| Measure |
Pantoprazole+Bismuth+Tetra+Metro
n=176 Participants
pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
|
(Panto+Amox+Clar+Metr)+(Panto+Amox)
n=176 Participants
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
|
|---|---|---|
|
Number of Participants in Which H. Pylori Was Eradicated
|
169 participants
|
170 participants
|
Adverse Events
Pantoprazole+Bismuth+Tetra+Metro
Serious events: 0 serious events
Other events: 86 other events
Deaths: 0 deaths
(Panto+Amox+Clar+Metr)+(Panto+Amox)
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pantoprazole+Bismuth+Tetra+Metro
n=176 participants at risk
pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
|
(Panto+Amox+Clar+Metr)+(Panto+Amox)
n=176 participants at risk
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
|
|---|---|---|
|
General disorders
Nausea
|
38.1%
67/176 • Number of events 67 • 2 months
|
8.5%
15/176 • Number of events 15 • 2 months
|
|
General disorders
Dizziness
|
7.4%
13/176 • Number of events 13 • 2 months
|
2.3%
4/176 • Number of events 4 • 2 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
5/176 • Number of events 5 • 2 months
|
4.0%
7/176 • Number of events 7 • 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.57%
1/176 • Number of events 1 • 2 months
|
4.0%
7/176 • Number of events 7 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place