NCT01575899

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.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Buddhist Tzu Chi General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 95 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2012-04-12
• Last updated: 2012-08-31
• Results posted: 2012-08-31

Locations

1 site across 1 country: Taiwan