Trial Condition(s):

Urinary Tract Infections

A Phase IV study of Cipro XR in uncomplicated UTI (EXPRESS)

Bayer Identifier:

100534

ClinicalTrials.gov Identifier:

NCT00663806

EudraCT Number:

Not Available

Study Completed

Trial 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.

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

Trial Summary

Enrollment Goal
7614
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Cipro XR (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

Locations
Status
LocationsStatus

Trial Design