A Phase IV Study of Cipro XR in Uncomplicated UTI - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00663806

Purpose

Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an educational brochure. - Women with urinary tract infections were treated with Cipro XR. They were also given a brochure with information about urinary tract infections and later tested on the information.

Condition	Intervention	Phase
Urinary Tract Infections	Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)	Phase IV

MedlinePlus related topics: Urinary Tract Infections

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction

Further study details as provided by Bayer:

Primary Outcome Measures:

To compare the effect on knowledge of uncomplicated urinary tract infection (uUTI) in patients who were given a disease-directed educational brochure to read versus patients who were not given the brochure. [ Time Frame: 3-10 days after start of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the difference between physician and patient perceptions of the symptoms of uUTI. [ Time Frame: At baseline visit pre-therapy ] [ Designated as safety issue: No ]
To collect data on the clinical efficacy and safety of Cipro XR, 500 mg, PO once daily, for 3 days, in the treatment of uUTI in a naturalistic setting. [ Time Frame: 1-3 days after end of therapy for efficacy and up to 30 days for safety ] [ Designated as safety issue: Yes ]

Enrollment:	7614
Study Start Date:	February 2003
Study Completion Date:	July 2003

Arms	Assigned Interventions
Arm 1: Experimental	Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939) Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI
Arm 2: Experimental	Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939) Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ambulatory women outpatients 18 to 65 years of age with a documented clinical diagnosis of uUTI characterized by dysuria with either urgency or frequency. Women of childbearing age were enrolled only if they were highly unlikely to conceive during the study and were practicing a suitable method of birth control or were at least 1 year postmenopausal.
Positive leukocyte esterase (>/= 1+) and positive nitrite test using a urine dipstick method of analysis.
Willing to give written consent.

Exclusion Criteria:

Pregnant or nursing
Complicated UTI
Allergy to Cipro XR

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663806

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head ( Bayer Healthcare Pharmaceuticals Inc. )
Study ID Numbers:	100534
Study First Received:	April 17, 2008
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00663806 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Bayer:

UTI

Study placed in the following topic categories:

Ciprofloxacin
Urologic Diseases
Urinary Tract Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Ciprofloxacin
Molecular Mechanisms of Pharmacological Action
Urologic Diseases
Therapeutic Uses

Urinary Tract Infections
Enzyme Inhibitors
Infection
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009