A Phase IV Study of Cipro XR in Uncomplicated UTI (EXPRESS)

Bayer

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infections

Treatments: Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663806

100534

Details and patient eligibility

About

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.

Enrollment: 7,614 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

7,614 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)

Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)

Arm 2

Experimental group

Treatment:

Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)

Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)