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

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.

Timeline

Start

2007-12

Primary completion

2009-12

Completion

2009-12

Outcome

Met primary endpoint

Stopped: “Early termination due to efficacy”

registry analysis (superiority or other test); Levofloxacin-Amox/Clav. vs Clarithromycin-Amoxicillin; p = 0.008; Odds Ratio (OR) 2.629 (95% CI 1.28 to 5.42); Chi-squared NCT01575899 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amoxicillin	Other / unclassified	1000 mg	—
Subject	Amoxicillin/clavulanate	Unknown	125 mg	—
Subject	Amoxicillin/clavulanate	Unknown	875 mg	—
Comparator	Clarithromycin	Small molecule	500 mg	—
Subject	Levofloxacin	Small molecule	500 mg	—
Comparator	Rabeprazole	Small molecule	20 mg	—

Indications