Trial Outcomes & Findings for Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection (NCT NCT01769365)
NCT ID: NCT01769365
Last Updated: 2017-11-17
Results Overview
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
307 participants
Primary outcome timeframe
at the 6th week after the end of anti- H. pylori therapy
Results posted on
2017-11-17
Participant Flow
We surveyed patients who visited the gastroenterological clinic of Kaohsiung Medical University Hospital (KMUH), Kaohsiung Veteran General Hospital (KVGH). A total of 307 H. pylori-infected patients were randomly assigned to triple (n=103 ) or sequential (n = 102) or concomitant (n = 102) therapies.
Participant milestones
| Measure |
7-day Quadruple Therapy
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
|
10-day Sequential Therapy
pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
|
7-day Standard Triple Therapy
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
103
|
|
Overall Study
COMPLETED
|
102
|
100
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection
Baseline characteristics by cohort
| Measure |
7-day Quadruple Therapy
n=102 Participants
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
|
10-day Sequential Therapy
n=102 Participants
pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
|
7-day Standard Triple Therapy
n=103 Participants
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
|
Total
n=307 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
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
211 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
|
Age, Continuous
|
53.85 years
STANDARD_DEVIATION 12.31 • n=99 Participants
|
54.96 years
STANDARD_DEVIATION 12.00 • n=107 Participants
|
56.08 years
STANDARD_DEVIATION 14.00 • n=206 Participants
|
54.88 years
STANDARD_DEVIATION 12.73 • n=7 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
132 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
175 Participants
n=7 Participants
|
|
Region of Enrollment
Taiwan
|
102 participants
n=99 Participants
|
102 participants
n=107 Participants
|
103 participants
n=206 Participants
|
307 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: at the 6th week after the end of anti- H. pylori therapyEvaluate eradication outcome by endoscopy urease test and histology or urea breath test
Outcome measures
| Measure |
7-day Quadruple Therapy
n=102 Participants
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
|
10-day Sequential Therapy
n=102 Participants
pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
|
7-day Standard Triple Therapy
n=103 Participants
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
|
|---|---|---|---|
|
Number of Participants With Complete Eradication of Helicobacter Pylori
|
102 participants
|
100 participants
|
101 participants
|
Adverse Events
7-day Standard Triple Therapy
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
7-day Quadruple Therapy
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
10-day Sequential Therapy
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
7-day Standard Triple Therapy
n=103 participants at risk
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
|
7-day Quadruple Therapy
n=102 participants at risk
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
|
10-day Sequential Therapy
n=102 participants at risk
pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.9%
3/103 • Number of events 3
|
6.9%
7/102 • Number of events 7
|
4.9%
5/102 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
4/103 • Number of events 4
|
6.9%
7/102 • Number of events 7
|
3.9%
4/102 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
3/103 • Number of events 3
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place