Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01667718

Collaborator

(none)

161

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.

Condition or Disease	Intervention/Treatment	Phase
Functional Dyspepsia Peptic Ulcer	Drug: Bismuth Drug: Lansoprazole Drug: Levoﬂoxacin Drug: Amoxicillin	Phase 4

Detailed Description

The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Study Design

Study Type:

Interventional

Actual Enrollment :

161 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Levofloxacin-containing Therapy for Helicobacter Pylori Treatment

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Levofloxacin-triple therapy Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin	Drug: Lansoprazole Lansoprazole 30 mg b.i.d.for 2 weeks Other Names: Proton Pump Inhibitor Drug: Levoﬂoxacin Levoﬂoxacin 0.5 q.d. for 2 weeks Drug: Amoxicillin Amoxicillin 1 g b.i.d. for 2 weeks
Experimental: Levofloxacin-quadruple therapy Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin	Drug: Bismuth Bismuth 220mg b.i.d for 2 weeks Other Names: Bismuth potassium citrate Drug: Lansoprazole Lansoprazole 30 mg b.i.d.for 2 weeks Other Names: Proton Pump Inhibitor Drug: Levoﬂoxacin Levoﬂoxacin 0.5 q.d. for 2 weeks Drug: Amoxicillin Amoxicillin 1 g b.i.d. for 2 weeks

Arm

Intervention/Treatment

Active Comparator: Levofloxacin-triple therapy

Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin

Drug: Lansoprazole

Lansoprazole 30 mg b.i.d.for 2 weeks

Other Names:

Proton Pump Inhibitor

Drug: Levoﬂoxacin

Levoﬂoxacin 0.5 q.d. for 2 weeks

Drug: Amoxicillin

Amoxicillin 1 g b.i.d. for 2 weeks

Experimental: Levofloxacin-quadruple therapy

Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin

Drug: Bismuth

Bismuth 220mg b.i.d for 2 weeks

Other Names:

Bismuth potassium citrate

Drug: Lansoprazole

Lansoprazole 30 mg b.i.d.for 2 weeks

Other Names:

Proton Pump Inhibitor

Drug: Levoﬂoxacin

Levoﬂoxacin 0.5 q.d. for 2 weeks

Drug: Amoxicillin

Amoxicillin 1 g b.i.d. for 2 weeks

Outcome Measures

Primary Outcome Measures

eradication rate of Helicobacter pylori [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer

Exclusion Criteria:

patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications