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

April 10, 2012
July 28, 2012
December 2007
December 2009   (final data collection date for primary outcome measure)
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.
Eradication rate [ 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.
Complete list of historical versions of study NCT01575899 on ClinicalTrials.gov Archive Site
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.
Not Provided
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.
Not Provided
 
Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori
Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Helicobacter Pylori Infection
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
208
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01575899
IRB096-28
Yes
Ming-Cheh Chen, Buddhist Tzu Chi General Hospital
Buddhist Tzu Chi General Hospital
Not Provided
Principal Investigator: Ming-Cheh CHEN, MD Buddhist Tzu Chi General Hospital
Buddhist Tzu Chi General Hospital
July 2012

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