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

NCT ID: NCT01575899

Last Updated: 2012-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-12-31

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Levofloxacin; Amoxicillin/clavulanate; Rabeprazole; Eastern Taiwan

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levofloxacin-Amoxicillin/clavulanate

7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.

Group Type: EXPERIMENTAL

Levofloxacin-Amox/clav.

Intervention Type: DRUG

Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days.

Clarithromycin-Amoxicillin

7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.

Group Type: ACTIVE_COMPARATOR

Clarithromycin-Amoxicillin

Intervention Type: DRUG

Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Levofloxacin(Cravit), Amoxicillin/clavulanate(Augmentin) and; Rabeprazole(Pariet) for 7 days.; Clarithromycin(Klaricid), Amoxicillin(Hiconcil) and; Rabeprazole(Pariet) for 7 days.

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ming-Cheh Chen

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming-Cheh CHEN, MD

Role: PRINCIPAL_INVESTIGATOR

Buddhist Tzu Chi General Hospital

Locations

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

IRB096-28

Identifier Type: -

Identifier Source: org_study_id