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

Functional Dyspepsia Clinical Trial

Official title:

Levofloxacin-containing Therapy for Helicobacter Pylori Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667718
• Other study ID #: rjkls2012011
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2012
• Last updated: December 12, 2012
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Renji Hospital, Shanghai Jiaotong University, School of Medicine:China
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Functional Dyspepsia
• Peptic Ulcer

Intervention

Drug:
• Bismuth
Bismuth 220mg b.i.d for 2 weeks
• Lansoprazole
Lansoprazole 30 mg b.i.d.for 2 weeks
• Levo?oxacin
Levo?oxacin 0.5 q.d. for 2 weeks
• Amoxicillin
Amoxicillin 1 g b.i.d. for 2 weeks

Locations

Country	Name	City	State
China	Shanghai Jiao-Tong University School of Medicine Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eradication rate of Helicobacter pylori		2 months	Yes