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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Levofloxacin-Amox/clav. Drug: Clarithromycin-Amoxicillin Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori.
Study Start Date : December 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Levofloxacin-Amoxicillin/clavulanate
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
 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.
Active Comparator: Clarithromycin-Amoxicillin
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575899


Locations
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Taiwan
Buddhist Tzu Chi General Hospital
Hualien, Taiwan, 97002
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
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Principal Investigator: Ming-Cheh CHEN, MD Buddhist Tzu Chi General Hospital
More Information
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Responsible Party: Ming-Cheh Chen, Principal investigator, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01575899    
Other Study ID Numbers: IRB096-28
First Posted: April 12, 2012    Key Record Dates
Results First Posted: August 31, 2012
Last Update Posted: August 31, 2012
Last Verified: July 2012
Keywords provided by Ming-Cheh Chen, Buddhist Tzu Chi General Hospital:
Helicobacter pylori
Levofloxacin
Amoxicillin/clavulanate
Rabeprazole
Eastern Taiwan
Additional relevant MeSH terms:
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Amoxicillin
Clarithromycin
Levofloxacin
Ofloxacin
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Rabeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
beta-Lactamase Inhibitors