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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
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • Eradication Rate (Participants Naive to Anti-H. Pylori Treatment) [ Time Frame: 4 weeks after complete use of drug for treatment ] [ Designated as safety issue: No ]
    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:
  • Eradication Rate of Participants Living in Rural Area. [ Time Frame: 4 weeks after complete use of drug for treatment ] [ Designated as safety issue: No ]
    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:
  • Re-eradication Rate [ Time Frame: 4 weeks after complete use of drug for treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 208
Study Start Date: December 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 95 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575899

Locations
Taiwan
Buddhist Tzu Chi General Hospital
Hualien, Taiwan, 97002
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
Principal Investigator: Ming-Cheh CHEN, MD Buddhist Tzu Chi General Hospital
  More Information

No publications provided

Responsible Party: Ming-Cheh Chen, Principal investigator, 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

Keywords provided by Buddhist Tzu Chi General Hospital:
Helicobacter pylori
Levofloxacin
Amoxicillin/clavulanate
Rabeprazole
Eastern Taiwan

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Ofloxacin
Amoxicillin-Potassium Clavulanate Combination
Clarithromycin
Clavulanic Acids
Clavulanic Acid
Rabeprazole
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Protein Synthesis Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013