Trial Outcomes & Findings for Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori (NCT NCT01575899)
NCT ID: NCT01575899
Last Updated: 2012-08-31
Results Overview
A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
208 participants
Primary outcome timeframe
4 weeks after complete use of drug for treatment
Results posted on
2012-08-31
Participant Flow
We included H. pylori-positive adult patients assessed by the rapid urease test and histology during the period December 2007 to December 2009 from the out-patient clinic of a single medical center located at Hualien, Eastern Taiwan.
We excluded patients under the age of 20, woman in pregnancy or breast feeding, those with concomitant illness or conditions (i.e., cardiopulmonary, hepatic, renal diseases, neoplastic diseases), those with severe complication of peptic ulcer disease, like obstruction or perforation, those with allergy to any of the drugs used.
Participant milestones
| Measure |
Levofloxacin-Amox/Clav.
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
|
Clarithromycin-Amoxicillin
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
|
Levofloxacin-Amox/Clav. (Re-eradication)
7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
73
|
62
|
|
Overall Study
COMPLETED
|
68
|
68
|
60
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
2
|
Reasons for withdrawal
| Measure |
Levofloxacin-Amox/Clav.
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
|
Clarithromycin-Amoxicillin
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
|
Levofloxacin-Amox/Clav. (Re-eradication)
7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
2
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
Baseline Characteristics
Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori
Baseline characteristics by cohort
| Measure |
Levofloxacin-Amox/Clav.
n=73 Participants
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
|
Clarithromycin-Amoxicillin
n=73 Participants
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
|
Levofloxacin-Amox/Clav. (Re-eradication)
n=62 Participants
7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
52.82 years
STANDARD_DEVIATION 12.08 • n=5 Participants
|
54.63 years
STANDARD_DEVIATION 14.42 • n=7 Participants
|
54.68 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
54.01 years
STANDARD_DEVIATION 12.77 • n=4 Participants
|
|
Age, Customized
< 54 years
|
38 participants
n=5 Participants
|
34 participants
n=7 Participants
|
25 participants
n=5 Participants
|
97 participants
n=4 Participants
|
|
Age, Customized
>=54 years
|
35 participants
n=5 Participants
|
39 participants
n=7 Participants
|
37 participants
n=5 Participants
|
111 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Resident area
Urban area
|
30 participants
n=5 Participants
|
24 participants
n=7 Participants
|
19 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Resident area
Rural area
|
43 participants
n=5 Participants
|
49 participants
n=7 Participants
|
43 participants
n=5 Participants
|
135 participants
n=4 Participants
|
|
Endoscopic finding
With peptic ulcer
|
30 participants
n=5 Participants
|
35 participants
n=7 Participants
|
21 participants
n=5 Participants
|
86 participants
n=4 Participants
|
|
Endoscopic finding
Without peptic ulcer
|
43 participants
n=5 Participants
|
38 participants
n=7 Participants
|
41 participants
n=5 Participants
|
122 participants
n=4 Participants
|
|
Follow up method
C13-UBT
|
65 participants
n=5 Participants
|
65 participants
n=7 Participants
|
55 participants
n=5 Participants
|
185 participants
n=4 Participants
|
|
Follow up method
CLO test
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Follow up method
No follow up
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after complete use of drug for treatmentPopulation: Intent to treat analysis of eradication (negative result of follow up method) measured 4 weeks after complete the treatment, for participants never received anti-H. pylori treatment before.
A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.
Outcome measures
| Measure |
Levofloxacin-Amox/Clav.
n=73 Participants
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
|
Clarithromycin-Amoxicillin
n=73 Participants
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
|
|---|---|---|
|
Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)
|
78.1 percentage of eradicated participants
|
57.5 percentage of eradicated participants
|
SECONDARY outcome
Timeframe: 4 weeks after complete use of drug for treatmentPopulation: Subgroup analysis (intent-to-treat) on eradication rate of participants who are living in rural area of Taiwan.
Subgroup analysis on eradication rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after treatment) according to resident area of participants, especially who are living in rural area.
Outcome measures
| Measure |
Levofloxacin-Amox/Clav.
n=43 Participants
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
|
Clarithromycin-Amoxicillin
n=49 Participants
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
|
|---|---|---|
|
Eradication Rate of Participants Living in Rural Area.
|
81.4 percentage of eradicated participants
|
51.3 percentage of eradicated participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks after complete use of drug for treatmentPopulation: This intent-to treat analysis is without control group, including patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.
Re-eradication successful rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after the 2nd treatment) with 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.
Outcome measures
| Measure |
Levofloxacin-Amox/Clav.
n=62 Participants
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
|
Clarithromycin-Amoxicillin
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
|
|---|---|---|
|
Re-eradication Rate
|
72.6 percentage of successful re-eradication
|
—
|
Adverse Events
Levofloxacin-Amox/Clav.
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Clarithromycin-Amoxicillin
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Levofloxacin-Amox/Clav. (Re-eradication)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levofloxacin-Amox/Clav.
n=73 participants at risk
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
|
Clarithromycin-Amoxicillin
n=73 participants at risk
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
|
Levofloxacin-Amox/Clav. (Re-eradication)
n=62 participants at risk
7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
|
|---|---|---|---|
|
Gastrointestinal disorders
Visited our emergency room
|
10.0%
1/10 • Number of events 1 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
0.00%
0/11 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
0.00%
0/17 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
Other adverse events
| Measure |
Levofloxacin-Amox/Clav.
n=73 participants at risk
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
|
Clarithromycin-Amoxicillin
n=73 participants at risk
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
|
Levofloxacin-Amox/Clav. (Re-eradication)
n=62 participants at risk
7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea / Hiccough
|
5.5%
4/73 • Number of events 4 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
5.5%
4/73 • Number of events 4 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
6.5%
4/62 • Number of events 4 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
|
Gastrointestinal disorders
Loose stool / Diarrhea
|
4.1%
3/73 • Number of events 3 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
1.4%
1/73 • Number of events 1 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
12.9%
8/62 • Number of events 8 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
|
Gastrointestinal disorders
Change in appetite / Bitter sensation
|
2.7%
2/73 • Number of events 2 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
5.5%
4/73 • Number of events 4 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
0.00%
0/62 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
|
Gastrointestinal disorders
Abdominal fullness / Flatus
|
1.4%
1/73 • Number of events 1 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
4.1%
3/73 • Number of events 3 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
6.5%
4/62 • Number of events 4 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
|
General disorders
Insomnia
|
1.4%
1/73 • Number of events 1 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
0.00%
0/73 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
6.5%
4/62 • Number of events 4 • Since participants enrolled into the study till completed the follow up, at least five weeks.
|
Additional Information
Dr. Ming-Cheh, Chen
Buddhist Tzu Chi General Hospital
Phone: +886-910-521003
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place