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Sponsored by: |
Bayer |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00669994 |
This trial evaluated how effective and safe Cipro XR was in treating female patients with signs and symptoms of a lower urinary tract infections. After 3 days of treatment, patients were evaluated to determine if signs/symptoms disappeared and the infecting bacteria was eliminated.
Condition | Intervention | Phase |
---|---|---|
Urinary Tract Infection |
Drug: Ciprofloxacin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Open Label Non-Comparative, Multi-Center Trial to Evaluate the Efficacy and Safety of Cipro® XR 500 mg Once Daily for 3 Days in Treating Female Patients With Acute, Uncomplicated, Symptomatic Lower Urinary Tract Infections |
Enrollment: | 300 |
Study Start Date: | July 2003 |
Study Completion Date: | October 2003 |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental
n/a
|
Drug: Ciprofloxacin
Cipro XR 500 mg tablets taken once daily
|
Ages Eligible for Study: | 18 Years to 44 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | ( Bayer Healthcare AG, Therapeutic Area Head ) |
Study ID Numbers: | 100546 |
Study First Received: | April 29, 2008 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00669994 |
Health Authority: | United States: Food and Drug Administration |
UTI Urinary Tract Infection |
Ciprofloxacin Urologic Diseases Urinary Tract Infections |
Anti-Infective Agents Communicable Diseases Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Infection Pharmacologic Actions Nucleic Acid Synthesis Inhibitors |