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

NCT01667718 | Completed Phase 4

• 1 other identifier: rjkls2012011
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Dyspepsia; Peptic Ulcer

Keywords

eradication; helicobacter pylori; bismuth

Outcome Measures

Primary Outcomes (1)

• eradication rate of Helicobacter pylori

  2 months

Study Arms (2)

Levofloxacin-triple therapy

ACTIVE COMPARATOR

Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin

Drug: Lansoprazole; Drug: Levofloxacin; Drug: Amoxicillin

Levofloxacin-quadruple therapy

EXPERIMENTAL

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

Drug: Bismuth; Drug: Lansoprazole; Drug: Levofloxacin; Drug: Amoxicillin

Interventions

Bismuth DRUG

Bismuth 220mg b.i.d for 2 weeks

Also known as: Bismuth potassium citrate

Levofloxacin-quadruple therapy

Lansoprazole DRUG

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

Also known as: Proton Pump Inhibitor

Levofloxacin-quadruple therapy; Levofloxacin-triple therapy

Levofloxacin DRUG

Levofloxacin 0.5 q.d. for 2 weeks

Levofloxacin-quadruple therapy; Levofloxacin-triple therapy

Amoxicillin DRUG

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

Levofloxacin-quadruple therapy; Levofloxacin-triple therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiao-Tong University School of Medicine Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Bismuth; Lansoprazole; Proton Pump Inhibitors; Amoxicillin

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Hong Lu

  Shanghai Jiao-Tong University School of Medicine Renji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of GI Division

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: August 17, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

CN (1)