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NCT00210886 - A Multicenter, Double-blind, Randomized Study to Compare the Efficacy and Safety of Levofloxacin 750 mg Once Daily for Five Days Versus Ciprofloxacin Twice Daily for Ten Days in the Treatment of Complicated Urinary Tract Infection and Acu

A Multicenter, Double-blind, Randomized Study to Compare the Efficacy and Safety of Levofloxacin 750 mg Once Daily for Five Days Versus Ciprofloxacin Twice Daily for Ten Days in the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis.


Data Specification

Annotated CRF

Available upon data request approval

Product Info

Generic Name
Levofloxacin
Product Name
LEVAQUIN®
Therapeutic Area
Urinary Tract, Sexual Organs, and Pregnancy Conditions
Enrollment
1,109
% Female
60.9%
% White
68.5%
Product Class
Quinolones - 3rd gen.
Sponsor Protocol Number
CAPSS-349
Data Partner
Johnson & Johnson
Condition Studied
Pyelonephritis, Urinary Tract Infections
Mean/Median Age (Years)
54.2

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.