Trial Outcomes & Findings for Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea (NCT NCT02159976)
NCT ID: NCT02159976
Last Updated: 2019-05-13
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
390 participants
Primary outcome timeframe
4 weeks after termination of eradication therapy, up to 6 weeks
Results posted on
2019-05-13
Participant Flow
Participant milestones
| Measure |
Sequential Therapy
pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)
Pantoprazole
Amoxicillin
Clarithromycin
Metronidazole
|
Modified Bismuth Quadruple Therapy
pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)
Pantoprazole
Amoxicillin
Tetracycline
Bismuth
|
|---|---|---|
|
Overall Study
STARTED
|
195
|
195
|
|
Overall Study
COMPLETED
|
165
|
170
|
|
Overall Study
NOT COMPLETED
|
30
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea
Baseline characteristics by cohort
| Measure |
Sequential Therapy
n=195 Participants
pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)
Pantoprazole
Amoxicillin
Clarithromycin
Metronidazole
|
Modified Bismuth Quadruple Therapy
n=195 Participants
pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)
Pantoprazole
Amoxicillin
Tetracycline
Bismuth
|
Total
n=390 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
|
|
Age, Categorical
Between 18 and 65 years
|
154 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
53.4 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
195 participants
n=5 Participants
|
195 participants
n=7 Participants
|
390 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after termination of eradication therapy, up to 6 weeksOutcome measures
| Measure |
Sequential Therapy
n=195 Participants
pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)
Pantoprazole
Amoxicillin
Clarithromycin
Metronidazole
|
Modified Bismuth Quadruple Therapy
n=195 Participants
pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)
Pantoprazole
Amoxicillin
Tetracycline
Bismuth
|
|---|---|---|
|
Counts of Participants With Successful H. Pylori Eradication
|
146 Participants
|
134 Participants
|
SECONDARY outcome
Timeframe: 4 weeks after termination of eradication therapy, up to 6 weeksOutcome measures
| Measure |
Sequential Therapy
n=176 Participants
pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)
Pantoprazole
Amoxicillin
Clarithromycin
Metronidazole
|
Modified Bismuth Quadruple Therapy
n=177 Participants
pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)
Pantoprazole
Amoxicillin
Tetracycline
Bismuth
|
|---|---|---|
|
Counts of Participants Whose Drug Compliance is More Than 85%
|
165 Participants
|
170 Participants
|
SECONDARY outcome
Timeframe: 4 weeks after termination of eradication therapy, up to 6 weeksOutcome measures
| Measure |
Sequential Therapy
n=195 Participants
pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)
Pantoprazole
Amoxicillin
Clarithromycin
Metronidazole
|
Modified Bismuth Quadruple Therapy
n=195 Participants
pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)
Pantoprazole
Amoxicillin
Tetracycline
Bismuth
|
|---|---|---|
|
Counts of Participants With Adverse Event
|
93 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: 1 year after termination of eradication therapyPopulation: SQT and PBAT were used for the initial treatment. Thereafter, treatment success and treatment failure group were divided. In the treatment failure group, secondary treatment was performed. Secondary endpoints were functional and dyspepsia symptom responses rate after successful treatment, not success in both treatment groups.
Outcome measures
| Measure |
Sequential Therapy
n=60 Participants
pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)
Pantoprazole
Amoxicillin
Clarithromycin
Metronidazole
|
Modified Bismuth Quadruple Therapy
n=3 Participants
pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)
Pantoprazole
Amoxicillin
Tetracycline
Bismuth
|
|---|---|---|
|
Functional Dyspepsia Symptom Responses Rate
complete (≥75%)
|
44 Participants
|
0 Participants
|
|
Functional Dyspepsia Symptom Responses Rate
Satisfactory (50-74%)
|
1 Participants
|
0 Participants
|
|
Functional Dyspepsia Symptom Responses Rate
Partial (25-49%)
|
6 Participants
|
1 Participants
|
|
Functional Dyspepsia Symptom Responses Rate
Refractory (<25%)
|
9 Participants
|
2 Participants
|
Adverse Events
Sequential Therapy
Serious events: 0 serious events
Other events: 93 other events
Deaths: 0 deaths
Modified Bismuth Quadruple Therapy
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sequential Therapy
n=195 participants at risk
pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)
Pantoprazole
Amoxicillin
Clarithromycin
Metronidazole
|
Modified Bismuth Quadruple Therapy
n=195 participants at risk
pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)
Pantoprazole
Amoxicillin
Tetracycline
Bismuth
|
|---|---|---|
|
Gastrointestinal disorders
Bloating
|
10.8%
21/195
|
5.6%
11/195
|
|
Gastrointestinal disorders
Epigastric soreness
|
7.7%
15/195
|
8.7%
17/195
|
|
Gastrointestinal disorders
Taste distortions
|
12.3%
24/195
|
2.1%
4/195
|
|
Gastrointestinal disorders
Nausea
|
7.2%
14/195
|
3.1%
6/195
|
|
Gastrointestinal disorders
Anorexia
|
1.0%
2/195
|
0.51%
1/195
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/195
|
1.0%
2/195
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
4/195
|
2.1%
4/195
|
|
Nervous system disorders
Headache
|
0.51%
1/195
|
1.0%
2/195
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
4/195
|
2.1%
4/195
|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
2/195
|
6.2%
12/195
|
|
Gastrointestinal disorders
Constipation
|
1.0%
2/195
|
1.5%
3/195
|
|
Gastrointestinal disorders
Reflux
|
0.51%
1/195
|
0.51%
1/195
|
|
Skin and subcutaneous tissue disorders
Rash and itching
|
1.0%
2/195
|
2.6%
5/195
|
|
Nervous system disorders
Dizziness
|
0.51%
1/195
|
0.00%
0/195
|
|
Gastrointestinal disorders
Stool color change
|
0.00%
0/195
|
1.5%
3/195
|
Additional Information
Nayoung Kim, M.D., Ph.D.
Department of Internal Medicine, Seoul National University Bundang Hospital
Phone: + 82-31-787-7008
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place