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
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|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: Levofloxacin-Amox/clav. Drug: Clarithromycin-Amoxicillin||Phase 4|
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.
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.
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.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days.
Active Comparator: Clarithromycin-Amoxicillin
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days.
- 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.
- 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.
- 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.
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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|
- Patient proved with infection of H. pylori in gastric mucosa
- Patient with signed informed consent.
- 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.
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
|Buddhist Tzu Chi General Hospital|
|Hualien, Taiwan, 97002|
|Principal Investigator:||Ming-Cheh CHEN, MD||Buddhist Tzu Chi General Hospital|
|Responsible Party:||Ming-Cheh Chen, Principal investigator, Buddhist Tzu Chi General Hospital|
|Other Study ID Numbers:||
|First Posted:||April 12, 2012 Key Record Dates|
|Results First Posted:||August 31, 2012|
|Last Update Posted:||August 31, 2012|
|Last Verified:||July 2012|
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