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Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori

Information source: Buddhist Tzu Chi General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Helicobacter Pylori Infection

Intervention: Levofloxacin-Amox/clav. (Drug); Clarithromycin-Amoxicillin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Buddhist Tzu Chi General Hospital

Official(s) and/or principal investigator(s):
Ming-Cheh CHEN, MD, Principal Investigator, Affiliation: Buddhist Tzu Chi General Hospital


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.

Clinical Details

Official title: Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)

Secondary outcome: Eradication Rate of Participants Living in Rural Area.

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.


Minimum age: 20 Years. Maximum age: 95 Years. Gender(s): Both.


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.

Locations and Contacts

Buddhist Tzu Chi General Hospital, Hualien 97002, Taiwan
Additional Information

Starting date: December 2007
Last updated: July 28, 2012

Page last updated: August 23, 2015

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