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Trial record 7 of 38 for:    "Bacterial Infectious Disease" | "Rabeprazole"

Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori

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ClinicalTrials.gov Identifier: NCT01575899
Recruitment Status : Terminated (Early termination due to efficacy)
First Posted : April 12, 2012
Results First Posted : August 31, 2012
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Ming-Cheh Chen, Buddhist Tzu Chi General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Helicobacter Pylori Infection
Interventions Drug: Levofloxacin-Amox/clav.
Drug: Clarithromycin-Amoxicillin
Enrollment 208
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Levofloxacin-Amox/Clav. Clarithromycin-Amoxicillin Levofloxacin-Amox/Clav. (Re-eradication)
Hide Arm/Group Description 7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication. 7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication. 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
Period Title: Overall Study
Started 73 73 62 [1]
Completed 68 68 60
Not Completed 5 5 2
Reason Not Completed
Lost to Follow-up             3             4             2
Protocol Violation             2             1             0
[1]
Included patients still with Hp infection after previous therapy without levofloxacin and Augmentin.
Arm/Group Title Levofloxacin-Amox/Clav. Clarithromycin-Amoxicillin Levofloxacin-Amox/Clav. (Re-eradication) Total
Hide Arm/Group Description 7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication. 7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication. 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication. Total of all reporting groups
Overall Number of Baseline Participants 73 73 62 208
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 73 participants 62 participants 208 participants
52.82  (12.08) 54.63  (14.42) 54.68  (11.81) 54.01  (12.77)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants 73 participants 62 participants 208 participants
< 54 years 38 34 25 97
>=54 years 35 39 37 111
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 73 participants 62 participants 208 participants
Female
35
  47.9%
40
  54.8%
38
  61.3%
113
  54.3%
Male
38
  52.1%
33
  45.2%
24
  38.7%
95
  45.7%
Resident area   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants 73 participants 62 participants 208 participants
Urban area 30 24 19 73
Rural area 43 49 43 135
[1]
Measure Description: Comparison about resident area of participants, living in urban area or rural area.
Endoscopic finding   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants 73 participants 62 participants 208 participants
With peptic ulcer 30 35 21 86
Without peptic ulcer 43 38 41 122
[1]
Measure Description: Comparison between participant's endoscopic finding with or without peptic ulcer disease.
Follow up method   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants 73 participants 62 participants 208 participants
C13-UBT 65 65 55 185
CLO test 5 4 5 14
No follow up 3 4 2 9
[1]
Measure Description: Information about the follow up method to confirmed the post-treatment Hp status of participants.
1.Primary Outcome
Title Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)
Hide Description A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.
Time Frame 4 weeks after complete use of drug for treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levofloxacin-Amox/Clav. Clarithromycin-Amoxicillin
Hide Arm/Group Description:
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: percentage of eradicated participants
78.1 57.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levofloxacin-Amox/Clav., Clarithromycin-Amoxicillin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.629
Confidence Interval (2-Sided) 95%
1.28 to 5.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.1526
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Eradication Rate of Participants Living in Rural Area.
Hide Description 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.
Time Frame 4 weeks after complete use of drug for treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup analysis (intent-to-treat) on eradication rate of participants who are living in rural area of Taiwan.
Arm/Group Title Levofloxacin-Amox/Clav. Clarithromycin-Amoxicillin
Hide Arm/Group Description:
Participants who are living in rural area and received 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for Hp eradication.
Participants who are living in rural area and received 7-day clarithromycin, amoxicillin and rabeprazole for Hp eradication.
Overall Number of Participants Analyzed 43 49
Measure Type: Number
Unit of Measure: percentage of eradicated participants
81.4 51.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levofloxacin-Amox/Clav., Clarithromycin-Amoxicillin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.87
Confidence Interval (2-Sided) 95%
1.5 to 10.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.2589
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Re-eradication Rate
Hide Description 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.
Time Frame 4 weeks after complete use of drug for treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This intent-to treat analysis is without control group, including patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.
Arm/Group Title Levofloxacin-Amox/Clav. (Re-eradication)
Hide Arm/Group Description:
7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: percentage of successful re-eradication
72.6
Time Frame Since participants enrolled into the study till completed the follow up, at least five weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levofloxacin-Amox/Clav. Clarithromycin-Amoxicillin Levofloxacin-Amox/Clav. (Re-eradication)
Hide Arm/Group Description 7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication. 7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication. 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
All-Cause Mortality
Levofloxacin-Amox/Clav. Clarithromycin-Amoxicillin Levofloxacin-Amox/Clav. (Re-eradication)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levofloxacin-Amox/Clav. Clarithromycin-Amoxicillin Levofloxacin-Amox/Clav. (Re-eradication)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/73 (1.37%)      0/73 (0.00%)      0/62 (0.00%)    
Gastrointestinal disorders       
Visited our emergency room * [1]  1/10 (10.00%)  1 0/11 (0.00%)  0 0/17 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Vomiting during eradication, visited our ER, improved after symptomatic treatment, then the case was loss in follow up.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Levofloxacin-Amox/Clav. Clarithromycin-Amoxicillin Levofloxacin-Amox/Clav. (Re-eradication)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/73 (13.70%)      11/73 (15.07%)      17/62 (27.42%)    
Gastrointestinal disorders       
Nausea / Hiccough * [1]  4/73 (5.48%)  4 4/73 (5.48%)  4 4/62 (6.45%)  4
Loose stool / Diarrhea * [2]  3/73 (4.11%)  3 1/73 (1.37%)  1 8/62 (12.90%)  8
Change in appetite / Bitter sensation * [3]  2/73 (2.74%)  2 4/73 (5.48%)  4 0/62 (0.00%)  0
Abdominal fullness / Flatus * [4]  1/73 (1.37%)  1 3/73 (4.11%)  3 4/62 (6.45%)  4
General disorders       
Insomnia * [5]  1/73 (1.37%)  1 0/73 (0.00%)  0 4/62 (6.45%)  4
*
Indicates events were collected by non-systematic assessment
[1]
Hiccough and/or sensation of nausea
[2]
Diarrhea or loose stool passage.
[3]
Bitter sensation in tongue, change in taste or appetite.
[4]
Flatus, abdominal fullness and gas passage.
[5]
Poor sleep.
The limitation of this study is the local primary resistance of Hp to levofloxacin and to amoxicillin/clavulanate is unknown. We are currently engaged in an on-going investigation of the influence of CYP2C19 genotypes on this new regimen.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ming-Cheh, Chen
Organization: Buddhist Tzu Chi General Hospital
Phone: +886-910-521003
Responsible Party: Ming-Cheh Chen, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01575899     History of Changes
Other Study ID Numbers: IRB096-28
First Submitted: April 10, 2012
First Posted: April 12, 2012
Results First Submitted: April 19, 2012
Results First Posted: August 31, 2012
Last Update Posted: August 31, 2012