Trial Information
Generic NameLevofloxacinProduct NameLEVAQUIN®Therapeutic AreaUrinary Tract, Sexual Organs, and Pregnancy ConditionsEnrollment1109% Female60.9%% White68.5%
Product ClassQuinolones - 3rd gen.Sponsor Protocol NumberCAPSS-349Data PartnerJohnson & JohnsonCondition StudiedPyelonephritis, Urinary Tract InfectionsMean/Median Age (Years)54.2
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2023-5195 : Predictive modeling of adverse events and symptoms patterns in large scale clinical trials
- 2022-4867 : Application of Bayesian Adaptive Designs in Phase III Clinical Trials
- 2015-0514 : Comparison of 5-Day Course of Levofloxacin vs 10-Day Course of Ciprofloxacin Therapy in Males with Urinary Tract Infection