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

This study has been terminated.
(Early termination due to efficacy)
Sponsor:
Information provided by (Responsible Party):
Ming-Cheh Chen, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01575899
First received: April 10, 2012
Last updated: July 28, 2012
Last verified: July 2012
Results First Received: April 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Helicobacter Pylori Infection
Interventions: Drug: Levofloxacin-Amox/clav.
Drug: Clarithromycin-Amoxicillin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Levofloxacin-Amox/Clav.   Clarithromycin-Amoxicillin   Levofloxacin-Amox/Clav. (Re-eradication)
STARTED   73   73   62 [1] 
COMPLETED   68   68   60 
NOT COMPLETED   5   5   2 
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Levofloxacin-Amox/Clav.   Clarithromycin-Amoxicillin   Levofloxacin-Amox/Clav. (Re-eradication)   Total 
Overall Participants Analyzed 
[Units: Participants]
 73   73   62   208 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.82  (12.08)   54.63  (14.42)   54.68  (11.81)   54.01  (12.77) 
Age, Customized 
[Units: Participants]
       
< 54 years   38   34   25   97 
>=54 years   35   39   37   111 
Gender 
[Units: Participants]
       
Female   35   40   38   113 
Male   38   33   24   95 
Resident area [1] 
[Units: Participants]
       
Urban area   30   24   19   73 
Rural area   43   49   43   135 
[1] Comparison about resident area of participants, living in urban area or rural area.
Endoscopic finding [1] 
[Units: Participants]
       
With peptic ulcer   30   35   21   86 
Without peptic ulcer   43   38   41   122 
[1] Comparison between participant's endoscopic finding with or without peptic ulcer disease.
Follow up method [1] 
[Units: Participants]
       
C13-UBT   65   65   55   185 
CLO test   5   4   5   14 
No follow up   3   4   2   9 
[1] Information about the follow up method to confirmed the post-treatment Hp status of participants.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)   [ Time Frame: 4 weeks after complete use of drug for treatment ]

2.  Secondary:   Eradication Rate of Participants Living in Rural Area.   [ Time Frame: 4 weeks after complete use of drug for treatment ]

3.  Other Pre-specified:   Re-eradication Rate   [ Time Frame: 4 weeks after complete use of drug for treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: MingCheh_chen@tzuchi.com.tw



Responsible Party: Ming-Cheh Chen, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01575899     History of Changes
Other Study ID Numbers: IRB096-28
Study First Received: April 10, 2012
Results First Received: April 19, 2012
Last Updated: July 28, 2012
Health Authority: Taiwan: Institutional Review Board