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

Phase 4

Terminated

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Levofloxacin-Amox/clav.; Drug: Clarithromycin-Amoxicillin

• Registration Number: NCT01575899
• Lead Sponsor: Buddhist Tzu Chi General Hospital

Brief 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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-12
• Results First Submitted: 2012-04-19
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-28
• Last Update Submitted: 2012-07-28
• Results First Posted: 2012-08-31
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levofloxacin-Amoxicillin/clavulanate	Levofloxacin-Amox/clav.	7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
Clarithromycin-Amoxicillin	Clarithromycin-Amoxicillin	7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.

Primary Outcome Measures

Name	Time	Method
Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)	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.

Secondary Outcome Measures

Name	Time	Method
Eradication Rate of Participants Living in Rural Area.	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.

Trial Locations

Locations (1)

Buddhist Tzu Chi General Hospital; 🇨🇳 Hualien, Taiwan