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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

Tracking Information
First Submitted Date  ICMJE April 10, 2012
First Posted Date  ICMJE April 12, 2012
Results First Submitted Date  ICMJE April 19, 2012
Results First Posted Date  ICMJE August 31, 2012
Last Update Posted Date August 31, 2012
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2012)
Eradication Rate (Participants Naive to Anti-H. Pylori Treatment) [ Time Frame: 4 weeks after complete use of drug for treatment ]
A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2012)
Eradication rate [ Time Frame: 4 weeks after complete use of drug for treatment ]
A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2012)
Eradication Rate of Participants Living in Rural Area. [ Time Frame: 4 weeks after complete use of drug for treatment ]
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 28, 2012)
Re-eradication Rate [ Time Frame: 4 weeks after complete use of drug for treatment ]
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori
Official Title  ICMJE Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori.
Brief Summary This prospective controlled randomized open-label clinical trial is designed to determine the eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in Eastern Taiwan.
Detailed Description

BACKGROUND:

The resistance rate of Helicobacter pylori (Hp) to amoxicillin and metronidazole therapy is significantly higher in Eastern Taiwan as compared to national and worldwide rates. The high resistance rate in this territory justified a search for a better eradication regimen for Hp infection.

AIM:

To evaluate the efficacy and tolerability of a combination therapeutic regimen of levofloxacin, amoxicillin/clavulanate and rabeprazole (LAcR) versus a conventional seven-day triple therapy with clarithromycin, amoxicillin and rabeprazole (CAR) for the eradication of Hp infection.

METHODS:

We conducted a open-labeled, prospective, randomized, controlled study in a large tertiary referral hospital in Eastern Taiwan. Hp-positive therapy-naïve patients with a positive CLO test as proven by gastroscopy were recruited for potential random assignment to two 7-day treatment groups: LAcR or CAR (control). The primary end point of this study was to evaluate the eradication rate of LAcR regimen. Hp eradication was assessed using the 13C-urea breath test or CLO test performed at least 4 weeks after end of treatment. Compliance and adverse effects with therapy were determined by phone call or outpatient clinic follow up.

EXPECTED RESULT:

The seven-day LAcR regimen evaluated in this study provided improved Hp eradication efficacy when compared with the traditional seven-day triple therapy in Eastern Taiwan.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Helicobacter Pylori Infection
Intervention  ICMJE
  • Drug: Levofloxacin-Amox/clav.
    Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days.
    Other Names:
    • Levofloxacin(Cravit), Amoxicillin/clavulanate(Augmentin) and
    • Rabeprazole(Pariet) for 7 days.
  • Drug: Clarithromycin-Amoxicillin
    Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days.
    Other Names:
    • Clarithromycin(Klaricid), Amoxicillin(Hiconcil) and
    • Rabeprazole(Pariet) for 7 days.
Study Arms  ICMJE
  • Experimental: Levofloxacin-Amoxicillin/clavulanate
    7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
    Intervention: Drug: Levofloxacin-Amox/clav.
  • Active Comparator: Clarithromycin-Amoxicillin
    7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
    Intervention: Drug: Clarithromycin-Amoxicillin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 28, 2012)
208
Original Actual Enrollment  ICMJE
 (submitted: April 11, 2012)
146
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient proved with infection of H. pylori in gastric mucosa
  • Patient with signed informed consent.

Exclusion Criteria:

  • woman in breast feeding or pregnancy.
  • allergy or severe adverse effects to drugs used in study.
  • severe complications of peptic ulcer disease (like perforation or obstruction).
  • patients with history of cancer or failure of major organs.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575899
Other Study ID Numbers  ICMJE IRB096-28
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ming-Cheh Chen, Buddhist Tzu Chi General Hospital
Study Sponsor  ICMJE Buddhist Tzu Chi General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ming-Cheh CHEN, MD Buddhist Tzu Chi General Hospital
PRS Account Buddhist Tzu Chi General Hospital
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP